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idK170491_s0_e2000

K170491.txt

proprietary and established names

Solana C. difficile Assay

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Proprietary and established names:

idK170491_s0_e2000

K170491.txt

regulation section

21 CFR 866.3130, Clostridium difficile toxin gene amplification assay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K170491 B. Purpose for Submission: To obtain a substantial equivalence determination for a new device C. Measurand: tcdA gene of toxigenic Clostridium difficile D. Type of Test: Qualitative Helicase-Dependent Amplification (HDA) assay E. Applicant: Quidel Corporation F. Proprietary and Established Names: Solana C. difficile Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3130, Clostridium difficile toxin gene amplification assay 2. Classification: II 3. Product code: OZN 4. Panel: Microbiology (83) 2 H. Intended Use: 1. Intended use(s): The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with the Solana instrument. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For prescription use only For in vitro diagnostic use only 4. Special instrument requirements: Solana instrument I. Device Description: The Solana C. difficile Assay combines sample processing and Helicase‐Dependent Amplification (HDA) performed in the Solana instrument for the detection of toxigenic Clostridium difficile directly from CDI‐suspected diarrheal specimens. The assay components include the Solana instrument, neonatal flocked swabs for specimen transfer, Lysis Tubes, Dilution Tubes, and Reaction Tubes. The Reaction Tubes contain lyophilized HDA reagents, dNTPs, primers and probes. The Lysis Tubes contain Lysis Buffer and include a competitive process control (PRC) to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. Solana amplifies and detects the target sequence and reports the test results to the user. A maximum of 12 tests can be performed on a single Solana instrument. Materials provided: · Neonatal flocked swabs · Lysis Tubes · Dilution Tubes · Reaction Tubes Materials required but not provided: · External controls for C. difficile (e.g., Quidel Molecular C. difficile Control Set, which contains positive and negative controls, serves as an external processing and extraction control) 3 · Sterile DNase‐free filter‐blocked or positive displacement micropipettor tips · Micropipettor · Stopwatch or timer · Scissors or a blade · Heat block capable of 95° C ± 2° C temperature · Solana workflow tray and transfer rack · Solana instrument · Thermometer J. Substantial Equivalence Information: 1. Predicate device name(s): Portrait Toxigenic C. difficile Assay 2. Predicate 510(k) number(s): K113358 (DEN120013) 3. Comparison with predicate: Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) Intended use The Solana C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile infection (CDI). The Solana C. difficile assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase‐dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence. The Solana C. difficile Assay is intended for use only with Portrait Toxigenic C. difficile Assay, a prescription device under 21 CFR Part 801.109 that is indicated for the detection of toxigenic Clostridium difficile in human fecal samples collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated blocked primer enabled helicase- dependent amplification (bpHDA) to detect toxin gene sequences associated with toxin producing C. difficile. The Portrait Toxigenic C. difficile Assay is intended as an aid in the 4 Similarities Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/DEN120013) the Solana instrument. diagnosis of CDI. Sample type Liquid or unformed stool Same Qualitative/Quantitative Qualitative Same Assay technology Isothermal helicase- dependent nucleic acid amplification Same Sample extraction Not required Same Detection method Automated Same Differences Item Device Solana C. difficile Assay Predicate Portrait Toxigenic C. difficile Assay (K113358/ DEN120013)) Assay target Toxin A gene (tcdA) Toxin B gene (tcdB) Instrument platform Solana instrument Portrait Analyzer Samples/controls per run 12 one K. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile, August 27, 2015. L. Test Principle: A small amount of specimen is transferred to a Lysis Tube using a swab. The Lysis Tube is then subjected to heat‐treatment at 95 °C for five minutes. The heat‐treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of target sequence. In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target‐specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. Upon annealing to target or PRC amplicons, the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on‐board method‐specific algorithms. Solana then report the test results to the user on its display screen, and it can print out the results via a printer. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To evaluate the reproducibility of the Solana C. difficile Assay, a blinded and randomized study panel was tested at one internal site and two external clinical sites. The panel was contrived in negative stool matrix and consisted of negative samples and positive samples spiked with toxigenic C. difficile at the following three organism concentration levels: moderate positive (3.4 x 103 CFU/mL), low positive (1.7 x 103 CFU/mL), and high negative (4.8 x 102 CFU/mL). Each site tested the panel and external positive and negative controls in triplicate for five non-consecutive days. Testing was conducted by two operators at each site with two runs per day. The Solana C. difficile Assay produced the expected results in 98.9% (89/90) of the low positive samples, 100% (90/90) of the moderate positive samples, and 100% (90/90) of the negative samples. The assay produced positive results in 47.8% (43/90) of the high negative samples which was within the expected range of 20 to 80% positive results. The results did not vary between sites, days, or runs. The external positive and negative controls produced the expected results for all replicates and no invalid control results were observed during the study. The reproducibility study results were acceptable. The results are summarized in Table 1. Table 1. Site-to-Site Reproducibility Results Sites Site #1 Site #2 Site #3 Overall Percent Agreement 95% Confidence Interval Category #expected results/ #tested % Agreement #expected results/ #tested % Agreement #expected results/ #tested % Agreement High Negative 12/30 40% 19/30 63.3% 12/30 40% 43/90 47.8% 37.8 - 58.0% Low Positive 30/30 100% 30/30 100% 29/30 96.7% Regulation section:

idK170491_s6000_e8000

K170491.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

was collected per patient. The specimens were processed and tested with Solana C. difficile Assay on the Solana instrument at the sites. Patient age, gender, and the percent positive results observed with the Solana C. difficile Assay for the combined sites are shown in Table 8. 14 Table 8. Combined Sites – Age and Gender Distributions Age/Gender Female Male Total Total % positive with the Solana C. difficile Assay < 2 years 3 3 6 16.7% (1/6) 3 to 11 years 4 6 10 20.0% (2/10) 12 to 17 years 4 10 14 7.1% (1/14) 18 to 21 years 11 14 25 24.0% (6/25) 22 to 59 years 206 132 338 14.2% (48/337*) > 60 years 268 193 461 12.0% (55/460*) Total 496 358 854 13.3% (113/852**) * One specimen was invalid ** Two specimens total were invalid N. Instrument Name: Solana instrument O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ________ or No ___X_____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 2. Software: The Solana® Instrument Software was reviewed and cleared as part of submission K150868. The additional information was provided in support of the Solana C. difficile Assay was reviewed and found acceptable. FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X_____ or No ________ 3. Specimen Identification: Specimens are identified by scanning a barcode or by manual entry. 15 4. Specimen Sampling and Handling: Raw stool specimens are sampled with the neonatal flocked swabs provided and transferred to a lysis tube. After heat lysis, 50µL of lysed sample is transferred to a dilution tube. Subsequently, 50µL of diluted sample is transferred to a reaction tube for automated amplification and detection. 5. Calibration: The end user is not required to calibrate the instrument. 6. Quality Control: See section M1c for information on internal and external controls. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK170491_s6000_e8000

K170491.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

single specimen was collected per patient. The specimens were processed and tested with Solana C. difficile Assay on the Solana instrument at the sites. Patient age, gender, and the percent positive results observed with the Solana C. difficile Assay for the combined sites are shown in Table 8. 14 Table 8. Combined Sites – Age and Gender Distributions Age/Gender Female Male Total Total % positive with the Solana C. difficile Assay < 2 years 3 3 6 16.7% (1/6) 3 to 11 years 4 6 10 20.0% (2/10) 12 to 17 years 4 10 14 7.1% (1/14) 18 to 21 years 11 14 25 24.0% (6/25) 22 to 59 years 206 132 338 14.2% (48/337*) > 60 years 268 193 461 12.0% (55/460*) Total 496 358 854 13.3% (113/852**) * One specimen was invalid ** Two specimens total were invalid N. Instrument Name: Solana instrument O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ________ or No ___X_____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 2. Software: The Solana® Instrument Software was reviewed and cleared as part of submission K150868. The additional information was provided in support of the Solana C. difficile Assay was reviewed and found acceptable. FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X_____ or No ________ 3. Specimen Identification: Specimens are identified by scanning a barcode or by manual entry. 15 4. Specimen Sampling and Handling: Raw stool specimens are sampled with the neonatal flocked swabs provided and transferred to a lysis tube. After heat lysis, 50µL of lysed sample is transferred to a dilution tube. Subsequently, 50µL of diluted sample is transferred to a reaction tube for automated amplification and detection. 5. Calibration: The end user is not required to calibrate the instrument. 6. Quality Control: See section M1c for information on internal and external controls. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK181043_s0_e2000

K181043.txt

measurand

Capillary whole blood glucose

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Measurand:

idK181043_s0_e2000

K181043.txt

type of test

Quantitative amperometric assay, glucose oxidase

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Type of test:

idK181043_s0_e2000

K181043.txt

classification

II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Classification:

idK181043_s0_e2000

K181043.txt

product code

PZI

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Product code:

idK181043_s0_e2000

K181043.txt

panel

Chemistry

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Panel:

idK181043_s0_e2000

K181043.txt

intended use

See Indications for Use below.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Intended use:

idK181043_s0_e2000

K181043.txt

predicate device name

Nova StatStrip Glucose Hospital Meter System

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Predicate device name:

idK181043_s0_e2000

K181043.txt

applicant

Nova Biomedical Corporation

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Applicant:

idK181043_s0_e2000

K181043.txt

proprietary and established names

StatStrip Glucose Hospital Meter System

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Proprietary and established names:

idK181043_s0_e2000

K181043.txt

regulation section

21 CFR 862.1345

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k181043 B. Purpose for Submission: This submission is a Dual 510(k) and CLIA Waiver by Application (Dual Submission) tracked as k181043 and CW180005. This 510(k) is to expand the indications for use for the StatStrip Glucose Hospital Meter System to include capillary whole blood samples for use in all hospitalized patients. C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay, glucose oxidase E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Glucose Hospital Meter System G. Regulatory Information: Product Code Regulation Name Classification Regulation Section Panel PZI Glucose Test System II 21 CFR 862.1345 Clinical Chemistry H. Intended Use: 1. Intended Use: See Indications for Use below. 2 2. Indications for Use: The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. 3. Special conditions for use statement(s): - For prescription use only - For in vitro diagnostic use only - The system has not been evaluated for use with neonate venous blood. - Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions. - Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated. - Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens. - Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used. - Use only whole blood. Do not use serum or plasma. - Should only be used with single-use, auto-disabling lancing devices - Caution should be exercised when testing capillary whole blood due to potential pre-analytical variability in capillary specimen collection. - A capillary whole blood specimen relies upon an adequate, non-compromised capillary blood flow. The healthcare provider must be aware that a capillary whole blood specimen glucose result may not always be the same as an arterial or a venous whole blood glucose result, especially when the patient’s condition is rapidly changing. - If a capillary whole blood glucose result is not consistent with a patient’s clinical signs and symptoms, glucose testing should be repeated with either an arterial or venous specimen on the StatStrip Glucose Hospital Meter System. 4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter I. Device Description: The StatStrip Glucose Hospital Meter System (previously cleared under k060345, k063821 and k132121 and k150281) consists of a hand held StatStrip Glucose Hospital meter, 3 StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual. Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345. J. Substantial Equivalence Information: 1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System 2. Predicate 510(k) number(s): k150281 3. Comparison with predicate: Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) Indications for Use/Intended Use Intended for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens for use in determining dysglycemia Same Population limitation Capillary whole blood specimens (e.g. obtained by finger stick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre- analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not truly reflect the patient’s true physiological state. Examples include, but are not limited to, severe Cleared for use with capillary fingerstick samples in all hospital patients including those receiving intensive medical intervention/therapy. 4 Similarities and Differences Item Predicate Device (k150281) Candidate Device (k181043) hypotension, shock, hyper- osmolar-hyperglycemia (with or without ketosis) and severe dehydration. Enzyme Glucose Oxidase Same Test Principle Electro-chemical biosensor Same Sample type Capillary finger stick, venous and arterial whole blood, neonatal arterial whole blood and neonatal heelstick. Same Measuring range 10-600 mg/dL Same Measuring time 6 sec Same Sample volume 1.2 μL Same Data storage 1000 Patient Test 200 QC Tests 4000 Operators Same Wi-Fi network connectivity Yes Same K. Standard/Guidance Document Referenced (if applicable): IEC 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements EN 60601-1-2:2007, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests L. Test Principle: The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measures blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Previously established in k060345. b. Linearity/assay reportable range: As established in k063821, the reportable range for the Nova StatStrip Glucose Hospital Meter System is 10 to 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability to NIST Standard SRM917B, as established in k060345. Test Strip: Test strip stability protocols and acceptance criteria were evaluated in k060345 and were found to be acceptable to support the claimed shelf life of 24 months at 33-86°F and 10-90% relative humidity (RH) and the claimed open-vial stability of 180 days when stored at the recommended storage temperatures 33-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips. d. Detection limit: This range was verified by the linearity established in k063821; section M.1.b. e. Analytical specificity: Potential interference from common endogenous and exogenous substances, as well as in vivo interference, was evaluated in k060345 and k132121. f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison study Performance for capillary finger stick, venous whole blood and arterial whole blood samples from non-hospitalized patients was established in k060345. Performance for neonatal heelstick and neonatal arterial samples was established in k063821. 6 Performance for venous and arterial, neonatal heelsticks and neonatal arterial samples from patients throughout the hospital was established in k132121. In this submission, additional comparison studies were performed using fingerstick capillary samples at three hospital sites as follows: Study 1 For Study 1, 568 capillary whole blood fingerstick specimens were obtained from patients within three different critical care units including the cardiovascular intensive care unit (CVICU), medical intensive care unit (MICU), and the operating room (OR). This study included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. All testing with the StatStrip Blood Glucose Hospital Meter (StatStrip Meter) was performed by CLIA waived operators (non-laboratory personnel, typically nursing staff) within each of these three critical care settings. Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, the Roche Cobas Modular P800 Hexokinase System, located in a central laboratory. The glucose ranges of the samples, Regulation section:

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panel

Chemistry

comparator method, ranged from 74 mg/dL to 379 mg/dL glucose. The results from the capillary fingerstick samples obtained from the StatStrip Hospital Meter compared to the results from the comparator method are summarized below: Fingertip capillary samples with glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 12 mg/dL Within ± 15 mg/dL Exceeds ± 15 mg/dL 1/1 (100%) 1/1 (100%) 1/1 (100%) 1/1 (100%) 0/1 (0%) Fingertip capillary samples with glucose concentrations ≥75 mg/dL Within ± 5 % Within ± 10 % Within ± 12 % Within ± 15 % Within ± 20 % Exceeds ± 20 % 277/567 (48.9%) 450/567 (79.4%) 484/567 (85.4%) 516/567 (91.0%) 549/567 (96.8%) 18/567 (3.2%) Study 2 Over 16,000 paired critical care capillary glucose specimens were retrospectively identified and met the following criteria: Within critical care departments, a capillary fingerstick specimen, and a venous/arterial glucose result were measured at the bedside by a CLIA Waived operator using the BGMS. Subsequently a plasma glucose test was performed on the same subject on the central laboratory hexokinase method within 15 minutes. 7 Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, Roche Cobas Modular P800 Hexokinase System. The glucose ranges of the samples, according to the comparator method, ranged from 27 mg/dL to 667 mg/dL glucose. The results from the capillary fingerstick samples obtained from the StatStrip Hospital Meter compared with the results from the comparator method are summarized below: Fingertip capillary samples with glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 12 mg/dL Within ± 15 mg/dL Exceeds ± 15 mg/dL 907/1894 (47.9%) 1470/1894 (77.6%) 1614/1894 (85.2%) 1737/1894 (91.7%) 157/1894 (8.3%) Fingertip capillary samples with glucose concentrations ≥75 mg/dL Within ± 5 % Within ± 10 % Within ± 12 % Within ± 15 % Within ± 20 % Exceeds ± 20 % 7473/14884 (50.2%) 11087/14884 (74.5%) 12799/14884 (86.0%) 13712/14884 (92.1%) 14350/14884 (96.4%) 534/14884 (3.6%) b. Matrix comparison Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Normal (non-diabetic) adult fasting: Less than 100 mg/dL (5.55 mmol/L) and less than 8 140 mg/dL (7.77 mmol/L) 1-2 hours after meals. American Diabetes Association. Classification and Diagnosis of Diabetes: Standards of Medical care in Diabetes. Diabetes Care (2018), Volume 41, Supplement 1. N. Instrument Name: Nova StatStrip Glucose Hospital Meter, previously cleared in k150281. O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X_____ or No ________ 3. Specimen Identification: The Nova StatStrip Glucose Hospital Meter memory will store 1000 patient tests, 200 QC tests, and 4000 operators. The meter contains a laser barcode scanner that allows for scanning patient identification information that may also be entered manually. 4. Specimen Sampling and Handling: The glucose test is intended to be used with capillary fingerstick whole blood, arterial, venous, neonatal heel stick and neonatal arterial. The blood sample is applied directly to the test strip by capillary action. The meter stores patient test data, quality control test data, and other information relating to the patient, patient sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, quality control preferences, and other operational settings are customizable. Data is transferred bi-directionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station. 9 5. Calibration: The meter does not require the user to input a test strip code or perform any other calibration. 6. Quality Control: Three levels of aqueous ready to use glucose control solutions are available with this system (Level 1, Level 2, and Level 3). Control solution testing can be performed by pushing the QC key, entering (or scanning) the test strip lot number. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the vial label of the control being used. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: 1) Hematocrit Study: As established in k060345 and k063821 to support the claimed hematocrit range of 20- 65%. 2) Altitude Study: As established in k060345 to support the use of the device up to 15,000 ft. 3) Temperature and humidity studies: As established in k060345 to support the claimed operating condition range of 59°F - 104°F and 10-90% relative humidity. 4) Infection Control Studies: The device is intended for multiple-patient use. Disinfection efficacy studies were performed (in k132121) on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipes, EPA registration # 67619-12 was validated for use with the meter. Robustness studies were also performed by the sponsor (in k132121) demonstrating that there was no change in performance or in the external materials of the modified StatStrip Glucose Hospital Meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) using the Clorox Germicidal Wipes to simulate 3 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 5) Electromagnetic Compatibility and Electrical Safety: Established in k150281. 6) Wireless Data Transmission Test: As established in k150281 to support functional use in a hospital environment. 10 7) Clinical Chemistry and Clinical Toxicology Devices Panel: A FDA meeting of the Clinical Chemistry and Clinical Toxicology Panel was held on March 30th, 3018, to discuss the benefits and risks of measuring capillary blood using blood glucose meters in patients receiving intensive medical intervention/therapy. The data from the 2 studies above using the Nova StatStrip meter were part of the data presented to the panel. The panel concluded that with respect to the performance data generated in the studies presented during the panel, the benefits outweigh the risk in this patient population receiving intensive medical intervention/therapy. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirement of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Panel:

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proposed labeling

The labeling is sufficient and it satisfies the requirement of 21 CFR Part 809.10.

method, ranged from 74 mg/dL to 379 mg/dL glucose. The results from the capillary fingerstick samples obtained from the StatStrip Hospital Meter compared to the results from the comparator method are summarized below: Fingertip capillary samples with glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 12 mg/dL Within ± 15 mg/dL Exceeds ± 15 mg/dL 1/1 (100%) 1/1 (100%) 1/1 (100%) 1/1 (100%) 0/1 (0%) Fingertip capillary samples with glucose concentrations ≥75 mg/dL Within ± 5 % Within ± 10 % Within ± 12 % Within ± 15 % Within ± 20 % Exceeds ± 20 % 277/567 (48.9%) 450/567 (79.4%) 484/567 (85.4%) 516/567 (91.0%) 549/567 (96.8%) 18/567 (3.2%) Study 2 Over 16,000 paired critical care capillary glucose specimens were retrospectively identified and met the following criteria: Within critical care departments, a capillary fingerstick specimen, and a venous/arterial glucose result were measured at the bedside by a CLIA Waived operator using the BGMS. Subsequently a plasma glucose test was performed on the same subject on the central laboratory hexokinase method within 15 minutes. 7 Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, Roche Cobas Modular P800 Hexokinase System. The glucose ranges of the samples, according to the comparator method, ranged from 27 mg/dL to 667 mg/dL glucose. The results from the capillary fingerstick samples obtained from the StatStrip Hospital Meter compared with the results from the comparator method are summarized below: Fingertip capillary samples with glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 12 mg/dL Within ± 15 mg/dL Exceeds ± 15 mg/dL 907/1894 (47.9%) 1470/1894 (77.6%) 1614/1894 (85.2%) 1737/1894 (91.7%) 157/1894 (8.3%) Fingertip capillary samples with glucose concentrations ≥75 mg/dL Within ± 5 % Within ± 10 % Within ± 12 % Within ± 15 % Within ± 20 % Exceeds ± 20 % 7473/14884 (50.2%) 11087/14884 (74.5%) 12799/14884 (86.0%) 13712/14884 (92.1%) 14350/14884 (96.4%) 534/14884 (3.6%) b. Matrix comparison Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Normal (non-diabetic) adult fasting: Less than 100 mg/dL (5.55 mmol/L) and less than 8 140 mg/dL (7.77 mmol/L) 1-2 hours after meals. American Diabetes Association. Classification and Diagnosis of Diabetes: Standards of Medical care in Diabetes. Diabetes Care (2018), Volume 41, Supplement 1. N. Instrument Name: Nova StatStrip Glucose Hospital Meter, previously cleared in k150281. O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X_____ or No ________ 3. Specimen Identification: The Nova StatStrip Glucose Hospital Meter memory will store 1000 patient tests, 200 QC tests, and 4000 operators. The meter contains a laser barcode scanner that allows for scanning patient identification information that may also be entered manually. 4. Specimen Sampling and Handling: The glucose test is intended to be used with capillary fingerstick whole blood, arterial, venous, neonatal heel stick and neonatal arterial. The blood sample is applied directly to the test strip by capillary action. The meter stores patient test data, quality control test data, and other information relating to the patient, patient sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, quality control preferences, and other operational settings are customizable. Data is transferred bi-directionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station. 9 5. Calibration: The meter does not require the user to input a test strip code or perform any other calibration. 6. Quality Control: Three levels of aqueous ready to use glucose control solutions are available with this system (Level 1, Level 2, and Level 3). Control solution testing can be performed by pushing the QC key, entering (or scanning) the test strip lot number. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the vial label of the control being used. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: 1) Hematocrit Study: As established in k060345 and k063821 to support the claimed hematocrit range of 20- 65%. 2) Altitude Study: As established in k060345 to support the use of the device up to 15,000 ft. 3) Temperature and humidity studies: As established in k060345 to support the claimed operating condition range of 59°F - 104°F and 10-90% relative humidity. 4) Infection Control Studies: The device is intended for multiple-patient use. Disinfection efficacy studies were performed (in k132121) on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipes, EPA registration # 67619-12 was validated for use with the meter. Robustness studies were also performed by the sponsor (in k132121) demonstrating that there was no change in performance or in the external materials of the modified StatStrip Glucose Hospital Meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) using the Clorox Germicidal Wipes to simulate 3 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 5) Electromagnetic Compatibility and Electrical Safety: Established in k150281. 6) Wireless Data Transmission Test: As established in k150281 to support functional use in a hospital environment. 10 7) Clinical Chemistry and Clinical Toxicology Devices Panel: A FDA meeting of the Clinical Chemistry and Clinical Toxicology Panel was held on March 30th, 3018, to discuss the benefits and risks of measuring capillary blood using blood glucose meters in patients receiving intensive medical intervention/therapy. The data from the 2 studies above using the Nova StatStrip meter were part of the data presented to the panel. The panel concluded that with respect to the performance data generated in the studies presented during the panel, the benefits outweigh the risk in this patient population receiving intensive medical intervention/therapy. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirement of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

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conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

comparator method, ranged from 74 mg/dL to 379 mg/dL glucose. The results from the capillary fingerstick samples obtained from the StatStrip Hospital Meter compared to the results from the comparator method are summarized below: Fingertip capillary samples with glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 12 mg/dL Within ± 15 mg/dL Exceeds ± 15 mg/dL 1/1 (100%) 1/1 (100%) 1/1 (100%) 1/1 (100%) 0/1 (0%) Fingertip capillary samples with glucose concentrations ≥75 mg/dL Within ± 5 % Within ± 10 % Within ± 12 % Within ± 15 % Within ± 20 % Exceeds ± 20 % 277/567 (48.9%) 450/567 (79.4%) 484/567 (85.4%) 516/567 (91.0%) 549/567 (96.8%) 18/567 (3.2%) Study 2 Over 16,000 paired critical care capillary glucose specimens were retrospectively identified and met the following criteria: Within critical care departments, a capillary fingerstick specimen, and a venous/arterial glucose result were measured at the bedside by a CLIA Waived operator using the BGMS. Subsequently a plasma glucose test was performed on the same subject on the central laboratory hexokinase method within 15 minutes. 7 Capillary whole blood glucose results on the StatStrip Meter were compared to matched arterial or venous plasma results obtained on a comparator method, Roche Cobas Modular P800 Hexokinase System. The glucose ranges of the samples, according to the comparator method, ranged from 27 mg/dL to 667 mg/dL glucose. The results from the capillary fingerstick samples obtained from the StatStrip Hospital Meter compared with the results from the comparator method are summarized below: Fingertip capillary samples with glucose concentrations <75 mg/dL Within ± 5 mg/dL Within ± 10 mg/dL Within ± 12 mg/dL Within ± 15 mg/dL Exceeds ± 15 mg/dL 907/1894 (47.9%) 1470/1894 (77.6%) 1614/1894 (85.2%) 1737/1894 (91.7%) 157/1894 (8.3%) Fingertip capillary samples with glucose concentrations ≥75 mg/dL Within ± 5 % Within ± 10 % Within ± 12 % Within ± 15 % Within ± 20 % Exceeds ± 20 % 7473/14884 (50.2%) 11087/14884 (74.5%) 12799/14884 (86.0%) 13712/14884 (92.1%) 14350/14884 (96.4%) 534/14884 (3.6%) b. Matrix comparison Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Normal (non-diabetic) adult fasting: Less than 100 mg/dL (5.55 mmol/L) and less than 8 140 mg/dL (7.77 mmol/L) 1-2 hours after meals. American Diabetes Association. Classification and Diagnosis of Diabetes: Standards of Medical care in Diabetes. Diabetes Care (2018), Volume 41, Supplement 1. N. Instrument Name: Nova StatStrip Glucose Hospital Meter, previously cleared in k150281. O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X_____ or No ________ 3. Specimen Identification: The Nova StatStrip Glucose Hospital Meter memory will store 1000 patient tests, 200 QC tests, and 4000 operators. The meter contains a laser barcode scanner that allows for scanning patient identification information that may also be entered manually. 4. Specimen Sampling and Handling: The glucose test is intended to be used with capillary fingerstick whole blood, arterial, venous, neonatal heel stick and neonatal arterial. The blood sample is applied directly to the test strip by capillary action. The meter stores patient test data, quality control test data, and other information relating to the patient, patient sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, quality control preferences, and other operational settings are customizable. Data is transferred bi-directionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station. 9 5. Calibration: The meter does not require the user to input a test strip code or perform any other calibration. 6. Quality Control: Three levels of aqueous ready to use glucose control solutions are available with this system (Level 1, Level 2, and Level 3). Control solution testing can be performed by pushing the QC key, entering (or scanning) the test strip lot number. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the vial label of the control being used. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: 1) Hematocrit Study: As established in k060345 and k063821 to support the claimed hematocrit range of 20- 65%. 2) Altitude Study: As established in k060345 to support the use of the device up to 15,000 ft. 3) Temperature and humidity studies: As established in k060345 to support the claimed operating condition range of 59°F - 104°F and 10-90% relative humidity. 4) Infection Control Studies: The device is intended for multiple-patient use. Disinfection efficacy studies were performed (in k132121) on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipes, EPA registration # 67619-12 was validated for use with the meter. Robustness studies were also performed by the sponsor (in k132121) demonstrating that there was no change in performance or in the external materials of the modified StatStrip Glucose Hospital Meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) using the Clorox Germicidal Wipes to simulate 3 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 5) Electromagnetic Compatibility and Electrical Safety: Established in k150281. 6) Wireless Data Transmission Test: As established in k150281 to support functional use in a hospital environment. 10 7) Clinical Chemistry and Clinical Toxicology Devices Panel: A FDA meeting of the Clinical Chemistry and Clinical Toxicology Panel was held on March 30th, 3018, to discuss the benefits and risks of measuring capillary blood using blood glucose meters in patients receiving intensive medical intervention/therapy. The data from the 2 studies above using the Nova StatStrip meter were part of the data presented to the panel. The panel concluded that with respect to the performance data generated in the studies presented during the panel, the benefits outweigh the risk in this patient population receiving intensive medical intervention/therapy. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirement of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

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New Submission

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151265 B. Purpose for Submission: New Submission C. Measurand: Capillary whole blood glucose from fingertip, palm, forearm, or upper arm. D. Type of Test: Quantitative Amperometric Assay; glucose dehydrogenase - flavin adenine dinucleotide (GDH-FAD) E. Applicant: SD Biosensor Inc. F. Proprietary and Established Names: SD GlucoNFC Blood Glucose Monitoring System SD GlucoNFC Multi Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 862.1345, Glucose Test System 862.1660, Quality control material (assayed and unassayed) 2. Classification: Class II Class I (reserved) 2 3. Product code: NBW - System, Test, Blood Glucose, Over-the-Counter LFR - Glucose Dehydrogenase, Glucose JJX - Single (specified) analyte controls (assayed and unassayed) 4. Panel: (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD Gluco NFC Blood Glucose Test Strips are for use with SD GlucoNFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.. SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm, or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should 3 only be used with auto-disabling, single-use lancing devices. The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm and venous whole blood. SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm, and venous whole blood. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly. 3. Special conditions for use statement(s): · For in vitro diagnostic use. · Do not use the system to test neonates. It has not been validated for neonatal use. · For the SD Gluco NFC BGMS: Critically ill patients should not be tested with this blood glucose meter. · For the SD GlucoNFC Multi BGMS: This device has not been evaluated in critically ill patients. · Not for diagnosis or screening of diabetes mellitus. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis. · Severe dehydration resulting from excessive water loss may cause false low results · Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly). · AST should not be used to calibrate continuous glucose monitors or in insulin dose calculations. · For the SD GlucoNFC Multi BGMS only: For use with single-use auto-disabling lancing devices. 4. Special instrument requirements: SD GlucoNFC meter SD GlucoNFC Multi meter 4 I. Device Description: SD GlucoNFC and SD GlucoNFC Multi Blood Glucose Monitoring Systems (BGMS) are over-the-counter and prescription blood glucose monitoring systems, respectively. The SD GlucoNFC BGMS is indicated for single-patient use at home and should not be shared, while the SD GlucoNFC Multi BGMS is for multi-patient use in a professional healthcare setting, in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology. The BGMS comes with the SD GlucoNFC or SDGlucoNFC Multi Blood Glucose Meter, one level of SD Navii Glucose Control Solution (Level 2), and SD GlucoNFC or SD GlucoNFC Multi Blood Glucose Test Strips. The SD Navii Glucose Control Solution is used to verify the performance of the SD GlucoNFC or SD GlucoNFC Multi BGMS. A second level of control (Level 3) is available for purchase separately. The device comes with a SD Glucose check strip, which is used to check the electronic performance of the meter. Use of the check strip does not take the place of running quality control solutions. J. Substantial Equivalence Information: 1. Predicate device name(s): SD GlucoMentor BGMS SD GlucoMentor Multi BGMS SD Check Gold Control Solutions 2. Predicate 510(k) number(s): K123517 3. Comparison with predicate: Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by people with diabetes at home to be used as an aid to monitor the effectiveness of diabetes control Same Test Time 5 seconds Same Measuring Range 20-600 mg/dL Same Test Principle Electrochemical biosensor Same 5 Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Sample Type Fresh capillary whole blood Same Sample Application Test strip capillary draw Same Calibration Plasma-calibrated Same Coding none Same Power Source 3V CR2032 Battery x1 (Replaceable) Same Monitor LCD display Same Backlight No Same Battery Life Approximately 1000 Tests Same Differences Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Hematocrit range 10-70% 10-60% Operating Temperature 46-113°F (8-45°C) 50-113°F (10-45°C) Operating Humidity 10-90% RH 15-90% RH Operating Altitude Up to 11, 480 ft. Up to 11,351 ft. Sample volume 0.5 mL 0.3 mL Test Strips SD GlucoNFC Blood Glucose Test Strips SD GlucoMentor Blood Glucose Test Strips Test Strip Technology Glucose Dehydrogenase (FAD) Glucose Oxidase (GOD) PC Link Feature USB Cable or NFC Reader/Writer USB Cable Smart device link feature Yes No Memory capacity 300 test results 500 test results Meter Dimensions 48 mm x 90 mm x 15 mm 47 mm x 95 mm x 17.5 mm Meter weight 50 g with battery 57.5 g with battery Similarities Item Candidate Device SD GlucoNFC Multi BGMS K151265 Predicate Device SD GlucoMentor Multi NFC K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn Purpose for submission:

idK151265_s0_e2000

K151265.txt

measurand

Capillary whole blood glucose from fingertip, palm, forearm, or upper arm.

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151265 B. Purpose for Submission: New Submission C. Measurand: Capillary whole blood glucose from fingertip, palm, forearm, or upper arm. D. Type of Test: Quantitative Amperometric Assay; glucose dehydrogenase - flavin adenine dinucleotide (GDH-FAD) E. Applicant: SD Biosensor Inc. F. Proprietary and Established Names: SD GlucoNFC Blood Glucose Monitoring System SD GlucoNFC Multi Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 862.1345, Glucose Test System 862.1660, Quality control material (assayed and unassayed) 2. Classification: Class II Class I (reserved) 2 3. Product code: NBW - System, Test, Blood Glucose, Over-the-Counter LFR - Glucose Dehydrogenase, Glucose JJX - Single (specified) analyte controls (assayed and unassayed) 4. Panel: (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD Gluco NFC Blood Glucose Test Strips are for use with SD GlucoNFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.. SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm, or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should 3 only be used with auto-disabling, single-use lancing devices. The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm and venous whole blood. SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm, and venous whole blood. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly. 3. Special conditions for use statement(s): · For in vitro diagnostic use. · Do not use the system to test neonates. It has not been validated for neonatal use. · For the SD Gluco NFC BGMS: Critically ill patients should not be tested with this blood glucose meter. · For the SD GlucoNFC Multi BGMS: This device has not been evaluated in critically ill patients. · Not for diagnosis or screening of diabetes mellitus. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis. · Severe dehydration resulting from excessive water loss may cause false low results · Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly). · AST should not be used to calibrate continuous glucose monitors or in insulin dose calculations. · For the SD GlucoNFC Multi BGMS only: For use with single-use auto-disabling lancing devices. 4. Special instrument requirements: SD GlucoNFC meter SD GlucoNFC Multi meter 4 I. Device Description: SD GlucoNFC and SD GlucoNFC Multi Blood Glucose Monitoring Systems (BGMS) are over-the-counter and prescription blood glucose monitoring systems, respectively. The SD GlucoNFC BGMS is indicated for single-patient use at home and should not be shared, while the SD GlucoNFC Multi BGMS is for multi-patient use in a professional healthcare setting, in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology. The BGMS comes with the SD GlucoNFC or SDGlucoNFC Multi Blood Glucose Meter, one level of SD Navii Glucose Control Solution (Level 2), and SD GlucoNFC or SD GlucoNFC Multi Blood Glucose Test Strips. The SD Navii Glucose Control Solution is used to verify the performance of the SD GlucoNFC or SD GlucoNFC Multi BGMS. A second level of control (Level 3) is available for purchase separately. The device comes with a SD Glucose check strip, which is used to check the electronic performance of the meter. Use of the check strip does not take the place of running quality control solutions. J. Substantial Equivalence Information: 1. Predicate device name(s): SD GlucoMentor BGMS SD GlucoMentor Multi BGMS SD Check Gold Control Solutions 2. Predicate 510(k) number(s): K123517 3. Comparison with predicate: Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by people with diabetes at home to be used as an aid to monitor the effectiveness of diabetes control Same Test Time 5 seconds Same Measuring Range 20-600 mg/dL Same Test Principle Electrochemical biosensor Same 5 Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Sample Type Fresh capillary whole blood Same Sample Application Test strip capillary draw Same Calibration Plasma-calibrated Same Coding none Same Power Source 3V CR2032 Battery x1 (Replaceable) Same Monitor LCD display Same Backlight No Same Battery Life Approximately 1000 Tests Same Differences Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Hematocrit range 10-70% 10-60% Operating Temperature 46-113°F (8-45°C) 50-113°F (10-45°C) Operating Humidity 10-90% RH 15-90% RH Operating Altitude Up to 11, 480 ft. Up to 11,351 ft. Sample volume 0.5 mL 0.3 mL Test Strips SD GlucoNFC Blood Glucose Test Strips SD GlucoMentor Blood Glucose Test Strips Test Strip Technology Glucose Dehydrogenase (FAD) Glucose Oxidase (GOD) PC Link Feature USB Cable or NFC Reader/Writer USB Cable Smart device link feature Yes No Memory capacity 300 test results 500 test results Meter Dimensions 48 mm x 90 mm x 15 mm 47 mm x 95 mm x 17.5 mm Meter weight 50 g with battery 57.5 g with battery Similarities Item Candidate Device SD GlucoNFC Multi BGMS K151265 Predicate Device SD GlucoMentor Multi NFC K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn Measurand:

idK151265_s0_e2000

K151265.txt

type of test

Quantitative Amperometric Assay; glucose dehydrogenase - flavin adenine dinucleotide (GDH-FAD)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151265 B. Purpose for Submission: New Submission C. Measurand: Capillary whole blood glucose from fingertip, palm, forearm, or upper arm. D. Type of Test: Quantitative Amperometric Assay; glucose dehydrogenase - flavin adenine dinucleotide (GDH-FAD) E. Applicant: SD Biosensor Inc. F. Proprietary and Established Names: SD GlucoNFC Blood Glucose Monitoring System SD GlucoNFC Multi Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 862.1345, Glucose Test System 862.1660, Quality control material (assayed and unassayed) 2. Classification: Class II Class I (reserved) 2 3. Product code: NBW - System, Test, Blood Glucose, Over-the-Counter LFR - Glucose Dehydrogenase, Glucose JJX - Single (specified) analyte controls (assayed and unassayed) 4. Panel: (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD Gluco NFC Blood Glucose Test Strips are for use with SD GlucoNFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.. SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm, or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should 3 only be used with auto-disabling, single-use lancing devices. The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm and venous whole blood. SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm, and venous whole blood. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly. 3. Special conditions for use statement(s): · For in vitro diagnostic use. · Do not use the system to test neonates. It has not been validated for neonatal use. · For the SD Gluco NFC BGMS: Critically ill patients should not be tested with this blood glucose meter. · For the SD GlucoNFC Multi BGMS: This device has not been evaluated in critically ill patients. · Not for diagnosis or screening of diabetes mellitus. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis. · Severe dehydration resulting from excessive water loss may cause false low results · Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly). · AST should not be used to calibrate continuous glucose monitors or in insulin dose calculations. · For the SD GlucoNFC Multi BGMS only: For use with single-use auto-disabling lancing devices. 4. Special instrument requirements: SD GlucoNFC meter SD GlucoNFC Multi meter 4 I. Device Description: SD GlucoNFC and SD GlucoNFC Multi Blood Glucose Monitoring Systems (BGMS) are over-the-counter and prescription blood glucose monitoring systems, respectively. The SD GlucoNFC BGMS is indicated for single-patient use at home and should not be shared, while the SD GlucoNFC Multi BGMS is for multi-patient use in a professional healthcare setting, in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology. The BGMS comes with the SD GlucoNFC or SDGlucoNFC Multi Blood Glucose Meter, one level of SD Navii Glucose Control Solution (Level 2), and SD GlucoNFC or SD GlucoNFC Multi Blood Glucose Test Strips. The SD Navii Glucose Control Solution is used to verify the performance of the SD GlucoNFC or SD GlucoNFC Multi BGMS. A second level of control (Level 3) is available for purchase separately. The device comes with a SD Glucose check strip, which is used to check the electronic performance of the meter. Use of the check strip does not take the place of running quality control solutions. J. Substantial Equivalence Information: 1. Predicate device name(s): SD GlucoMentor BGMS SD GlucoMentor Multi BGMS SD Check Gold Control Solutions 2. Predicate 510(k) number(s): K123517 3. Comparison with predicate: Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by people with diabetes at home to be used as an aid to monitor the effectiveness of diabetes control Same Test Time 5 seconds Same Measuring Range 20-600 mg/dL Same Test Principle Electrochemical biosensor Same 5 Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Sample Type Fresh capillary whole blood Same Sample Application Test strip capillary draw Same Calibration Plasma-calibrated Same Coding none Same Power Source 3V CR2032 Battery x1 (Replaceable) Same Monitor LCD display Same Backlight No Same Battery Life Approximately 1000 Tests Same Differences Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Hematocrit range 10-70% 10-60% Operating Temperature 46-113°F (8-45°C) 50-113°F (10-45°C) Operating Humidity 10-90% RH 15-90% RH Operating Altitude Up to 11, 480 ft. Up to 11,351 ft. Sample volume 0.5 mL 0.3 mL Test Strips SD GlucoNFC Blood Glucose Test Strips SD GlucoMentor Blood Glucose Test Strips Test Strip Technology Glucose Dehydrogenase (FAD) Glucose Oxidase (GOD) PC Link Feature USB Cable or NFC Reader/Writer USB Cable Smart device link feature Yes No Memory capacity 300 test results 500 test results Meter Dimensions 48 mm x 90 mm x 15 mm 47 mm x 95 mm x 17.5 mm Meter weight 50 g with battery 57.5 g with battery Similarities Item Candidate Device SD GlucoNFC Multi BGMS K151265 Predicate Device SD GlucoMentor Multi NFC K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn Type of test:

idK151265_s0_e2000

K151265.txt

panel

(75) Chemistry

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151265 B. Purpose for Submission: New Submission C. Measurand: Capillary whole blood glucose from fingertip, palm, forearm, or upper arm. D. Type of Test: Quantitative Amperometric Assay; glucose dehydrogenase - flavin adenine dinucleotide (GDH-FAD) E. Applicant: SD Biosensor Inc. F. Proprietary and Established Names: SD GlucoNFC Blood Glucose Monitoring System SD GlucoNFC Multi Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 862.1345, Glucose Test System 862.1660, Quality control material (assayed and unassayed) 2. Classification: Class II Class I (reserved) 2 3. Product code: NBW - System, Test, Blood Glucose, Over-the-Counter LFR - Glucose Dehydrogenase, Glucose JJX - Single (specified) analyte controls (assayed and unassayed) 4. Panel: (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD Gluco NFC Blood Glucose Test Strips are for use with SD GlucoNFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.. SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm, or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should 3 only be used with auto-disabling, single-use lancing devices. The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm and venous whole blood. SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm, and venous whole blood. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly. 3. Special conditions for use statement(s): · For in vitro diagnostic use. · Do not use the system to test neonates. It has not been validated for neonatal use. · For the SD Gluco NFC BGMS: Critically ill patients should not be tested with this blood glucose meter. · For the SD GlucoNFC Multi BGMS: This device has not been evaluated in critically ill patients. · Not for diagnosis or screening of diabetes mellitus. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis. · Severe dehydration resulting from excessive water loss may cause false low results · Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly). · AST should not be used to calibrate continuous glucose monitors or in insulin dose calculations. · For the SD GlucoNFC Multi BGMS only: For use with single-use auto-disabling lancing devices. 4. Special instrument requirements: SD GlucoNFC meter SD GlucoNFC Multi meter 4 I. Device Description: SD GlucoNFC and SD GlucoNFC Multi Blood Glucose Monitoring Systems (BGMS) are over-the-counter and prescription blood glucose monitoring systems, respectively. The SD GlucoNFC BGMS is indicated for single-patient use at home and should not be shared, while the SD GlucoNFC Multi BGMS is for multi-patient use in a professional healthcare setting, in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology. The BGMS comes with the SD GlucoNFC or SDGlucoNFC Multi Blood Glucose Meter, one level of SD Navii Glucose Control Solution (Level 2), and SD GlucoNFC or SD GlucoNFC Multi Blood Glucose Test Strips. The SD Navii Glucose Control Solution is used to verify the performance of the SD GlucoNFC or SD GlucoNFC Multi BGMS. A second level of control (Level 3) is available for purchase separately. The device comes with a SD Glucose check strip, which is used to check the electronic performance of the meter. Use of the check strip does not take the place of running quality control solutions. J. Substantial Equivalence Information: 1. Predicate device name(s): SD GlucoMentor BGMS SD GlucoMentor Multi BGMS SD Check Gold Control Solutions 2. Predicate 510(k) number(s): K123517 3. Comparison with predicate: Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by people with diabetes at home to be used as an aid to monitor the effectiveness of diabetes control Same Test Time 5 seconds Same Measuring Range 20-600 mg/dL Same Test Principle Electrochemical biosensor Same 5 Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Sample Type Fresh capillary whole blood Same Sample Application Test strip capillary draw Same Calibration Plasma-calibrated Same Coding none Same Power Source 3V CR2032 Battery x1 (Replaceable) Same Monitor LCD display Same Backlight No Same Battery Life Approximately 1000 Tests Same Differences Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Hematocrit range 10-70% 10-60% Operating Temperature 46-113°F (8-45°C) 50-113°F (10-45°C) Operating Humidity 10-90% RH 15-90% RH Operating Altitude Up to 11, 480 ft. Up to 11,351 ft. Sample volume 0.5 mL 0.3 mL Test Strips SD GlucoNFC Blood Glucose Test Strips SD GlucoMentor Blood Glucose Test Strips Test Strip Technology Glucose Dehydrogenase (FAD) Glucose Oxidase (GOD) PC Link Feature USB Cable or NFC Reader/Writer USB Cable Smart device link feature Yes No Memory capacity 300 test results 500 test results Meter Dimensions 48 mm x 90 mm x 15 mm 47 mm x 95 mm x 17.5 mm Meter weight 50 g with battery 57.5 g with battery Similarities Item Candidate Device SD GlucoNFC Multi BGMS K151265 Predicate Device SD GlucoMentor Multi NFC K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn Panel:

idK151265_s0_e2000

K151265.txt

intended use

See indications for use below.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151265 B. Purpose for Submission: New Submission C. Measurand: Capillary whole blood glucose from fingertip, palm, forearm, or upper arm. D. Type of Test: Quantitative Amperometric Assay; glucose dehydrogenase - flavin adenine dinucleotide (GDH-FAD) E. Applicant: SD Biosensor Inc. F. Proprietary and Established Names: SD GlucoNFC Blood Glucose Monitoring System SD GlucoNFC Multi Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 862.1345, Glucose Test System 862.1660, Quality control material (assayed and unassayed) 2. Classification: Class II Class I (reserved) 2 3. Product code: NBW - System, Test, Blood Glucose, Over-the-Counter LFR - Glucose Dehydrogenase, Glucose JJX - Single (specified) analyte controls (assayed and unassayed) 4. Panel: (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD Gluco NFC Blood Glucose Test Strips are for use with SD GlucoNFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.. SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm, or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should 3 only be used with auto-disabling, single-use lancing devices. The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm and venous whole blood. SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm, and venous whole blood. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly. 3. Special conditions for use statement(s): · For in vitro diagnostic use. · Do not use the system to test neonates. It has not been validated for neonatal use. · For the SD Gluco NFC BGMS: Critically ill patients should not be tested with this blood glucose meter. · For the SD GlucoNFC Multi BGMS: This device has not been evaluated in critically ill patients. · Not for diagnosis or screening of diabetes mellitus. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis. · Severe dehydration resulting from excessive water loss may cause false low results · Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly). · AST should not be used to calibrate continuous glucose monitors or in insulin dose calculations. · For the SD GlucoNFC Multi BGMS only: For use with single-use auto-disabling lancing devices. 4. Special instrument requirements: SD GlucoNFC meter SD GlucoNFC Multi meter 4 I. Device Description: SD GlucoNFC and SD GlucoNFC Multi Blood Glucose Monitoring Systems (BGMS) are over-the-counter and prescription blood glucose monitoring systems, respectively. The SD GlucoNFC BGMS is indicated for single-patient use at home and should not be shared, while the SD GlucoNFC Multi BGMS is for multi-patient use in a professional healthcare setting, in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology. The BGMS comes with the SD GlucoNFC or SDGlucoNFC Multi Blood Glucose Meter, one level of SD Navii Glucose Control Solution (Level 2), and SD GlucoNFC or SD GlucoNFC Multi Blood Glucose Test Strips. The SD Navii Glucose Control Solution is used to verify the performance of the SD GlucoNFC or SD GlucoNFC Multi BGMS. A second level of control (Level 3) is available for purchase separately. The device comes with a SD Glucose check strip, which is used to check the electronic performance of the meter. Use of the check strip does not take the place of running quality control solutions. J. Substantial Equivalence Information: 1. Predicate device name(s): SD GlucoMentor BGMS SD GlucoMentor Multi BGMS SD Check Gold Control Solutions 2. Predicate 510(k) number(s): K123517 3. Comparison with predicate: Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by people with diabetes at home to be used as an aid to monitor the effectiveness of diabetes control Same Test Time 5 seconds Same Measuring Range 20-600 mg/dL Same Test Principle Electrochemical biosensor Same 5 Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Sample Type Fresh capillary whole blood Same Sample Application Test strip capillary draw Same Calibration Plasma-calibrated Same Coding none Same Power Source 3V CR2032 Battery x1 (Replaceable) Same Monitor LCD display Same Backlight No Same Battery Life Approximately 1000 Tests Same Differences Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Hematocrit range 10-70% 10-60% Operating Temperature 46-113°F (8-45°C) 50-113°F (10-45°C) Operating Humidity 10-90% RH 15-90% RH Operating Altitude Up to 11, 480 ft. Up to 11,351 ft. Sample volume 0.5 mL 0.3 mL Test Strips SD GlucoNFC Blood Glucose Test Strips SD GlucoMentor Blood Glucose Test Strips Test Strip Technology Glucose Dehydrogenase (FAD) Glucose Oxidase (GOD) PC Link Feature USB Cable or NFC Reader/Writer USB Cable Smart device link feature Yes No Memory capacity 300 test results 500 test results Meter Dimensions 48 mm x 90 mm x 15 mm 47 mm x 95 mm x 17.5 mm Meter weight 50 g with battery 57.5 g with battery Similarities Item Candidate Device SD GlucoNFC Multi BGMS K151265 Predicate Device SD GlucoMentor Multi NFC K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn Intended use:

idK151265_s0_e2000

K151265.txt

applicant

SD Biosensor Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K151265 B. Purpose for Submission: New Submission C. Measurand: Capillary whole blood glucose from fingertip, palm, forearm, or upper arm. D. Type of Test: Quantitative Amperometric Assay; glucose dehydrogenase - flavin adenine dinucleotide (GDH-FAD) E. Applicant: SD Biosensor Inc. F. Proprietary and Established Names: SD GlucoNFC Blood Glucose Monitoring System SD GlucoNFC Multi Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 862.1345, Glucose Test System 862.1660, Quality control material (assayed and unassayed) 2. Classification: Class II Class I (reserved) 2 3. Product code: NBW - System, Test, Blood Glucose, Over-the-Counter LFR - Glucose Dehydrogenase, Glucose JJX - Single (specified) analyte controls (assayed and unassayed) 4. Panel: (75) Chemistry H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: SD GlucoNFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm. SD GlucoNFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self- testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The SD GlucoNFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD Gluco NFC Blood Glucose Test Strips are for use with SD GlucoNFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly.. SD GlucoNFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm, or upper arm and venous whole blood. The SD GlucoNFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should 3 only be used with auto-disabling, single-use lancing devices. The SD GlucoNFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNFC Multi Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm and venous whole blood. SD GlucoNFC Multi Blood Glucose Test Strips are for use with SD GlucoNFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm, and venous whole blood. SD GlucoNavii Control Solution is intended for Quality Control of the SD GlucoNFC Blood Glucose Monitoring System. The control solution helps to check that the meter and test strips are working together properly and that the test is performing correctly. 3. Special conditions for use statement(s): · For in vitro diagnostic use. · Do not use the system to test neonates. It has not been validated for neonatal use. · For the SD Gluco NFC BGMS: Critically ill patients should not be tested with this blood glucose meter. · For the SD GlucoNFC Multi BGMS: This device has not been evaluated in critically ill patients. · Not for diagnosis or screening of diabetes mellitus. · Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar state, with or without ketosis. · Severe dehydration resulting from excessive water loss may cause false low results · Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly). · AST should not be used to calibrate continuous glucose monitors or in insulin dose calculations. · For the SD GlucoNFC Multi BGMS only: For use with single-use auto-disabling lancing devices. 4. Special instrument requirements: SD GlucoNFC meter SD GlucoNFC Multi meter 4 I. Device Description: SD GlucoNFC and SD GlucoNFC Multi Blood Glucose Monitoring Systems (BGMS) are over-the-counter and prescription blood glucose monitoring systems, respectively. The SD GlucoNFC BGMS is indicated for single-patient use at home and should not be shared, while the SD GlucoNFC Multi BGMS is for multi-patient use in a professional healthcare setting, in order to help monitor the effectiveness of diabetes control. The devices contain near field communication (NFC) technology. The BGMS comes with the SD GlucoNFC or SDGlucoNFC Multi Blood Glucose Meter, one level of SD Navii Glucose Control Solution (Level 2), and SD GlucoNFC or SD GlucoNFC Multi Blood Glucose Test Strips. The SD Navii Glucose Control Solution is used to verify the performance of the SD GlucoNFC or SD GlucoNFC Multi BGMS. A second level of control (Level 3) is available for purchase separately. The device comes with a SD Glucose check strip, which is used to check the electronic performance of the meter. Use of the check strip does not take the place of running quality control solutions. J. Substantial Equivalence Information: 1. Predicate device name(s): SD GlucoMentor BGMS SD GlucoMentor Multi BGMS SD Check Gold Control Solutions 2. Predicate 510(k) number(s): K123517 3. Comparison with predicate: Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by people with diabetes at home to be used as an aid to monitor the effectiveness of diabetes control Same Test Time 5 seconds Same Measuring Range 20-600 mg/dL Same Test Principle Electrochemical biosensor Same 5 Similarities Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Sample Type Fresh capillary whole blood Same Sample Application Test strip capillary draw Same Calibration Plasma-calibrated Same Coding none Same Power Source 3V CR2032 Battery x1 (Replaceable) Same Monitor LCD display Same Backlight No Same Battery Life Approximately 1000 Tests Same Differences Item Candidate Device SD GlucoNFC K151265 Predicate Device SD GlucoMentor BGMS K123517 Hematocrit range 10-70% 10-60% Operating Temperature 46-113°F (8-45°C) 50-113°F (10-45°C) Operating Humidity 10-90% RH 15-90% RH Operating Altitude Up to 11, 480 ft. Up to 11,351 ft. Sample volume 0.5 mL 0.3 mL Test Strips SD GlucoNFC Blood Glucose Test Strips SD GlucoMentor Blood Glucose Test Strips Test Strip Technology Glucose Dehydrogenase (FAD) Glucose Oxidase (GOD) PC Link Feature USB Cable or NFC Reader/Writer USB Cable Smart device link feature Yes No Memory capacity 300 test results 500 test results Meter Dimensions 48 mm x 90 mm x 15 mm 47 mm x 95 mm x 17.5 mm Meter weight 50 g with battery 57.5 g with battery Similarities Item Candidate Device SD GlucoNFC Multi BGMS K151265 Predicate Device SD GlucoMentor Multi NFC K123517 Intended Use Monitoring glucose in fresh capillary whole blood samples drawn Applicant:

idK171971_s0_e2000

K171971.txt

purpose for submission

New Device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measurand: Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA) D. Type of Test: Quantitative, photometric/colorimetric E. Applicant: Lite-On Technology Corp. F. Proprietary and Established Names: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer G. Regulatory Information: Regulation description Product Code Device Class Regulation Number Panel Alkaline Phosphatase test system CJE Class II 862.1050 Clinical Chemistry (75) Blood Urea Nitrogen test system CDN Class II 862.1770 Creatinine test system CGX Class II 862.1225 Aspartate aminotransferase (AST/SGOT) test system CIT Class II 862.1100 Alanine amino transferase (ALT/SGPT) test system CKA Class I 862.1030 Analyzer, chemistry, centrifugal, for clinical use JJG Class I 862.2160 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. 3. Special conditions for use statement(s): For prescription use only at point-of-care (POC) and clinical laboratory settings. 4. Special instrument requirements: skyla Clinical Chemistry Analyzer or Minicare C300 Clinical Chemistry Analyzer 3 I. Device Description: The Comprehensive Metabolic Panel contains a set of dried reagents that are used in the quantitative testing of various substances in the blood sample. The Comprehensive Metabolic Panel reagent discs are designed to separate a heparinized venous whole blood sample into plasma and blood cells, quantity the amount of plasma and diluent through the metering function of disc, mix both of plasma and diluent, and deliver the mixture to each reaction wells where the dried reagent are present to initiate the chemical reactions that are then measured by analyzer. Alternately, the disc may also be used with heparinized plasma only and serum sample. The skyla Clinical Chemistry System consists of a portable analyzer and single-use disposable reagent panel discs. The analyzers utilize precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel. The analyzer contains the following features and components: · Compatibility with lithium-heparinized venous whole blood samples without the need for sample dilution. · Operation by a colored touchscreen panel · Fully automated system for simple operation · Rapid analysis, reporting test results in approximately 15 minutes · Power-on self-test capability, ensuring instrument stability · Internal quality control functionality, ensuring reliable test results · Built-in thermal printer for immediate printing of the test results The Minicare C300 Clinical Chemistry Analyzer has the identical design and specifications of skyla Clinical Chemistry Analyzer, except the appearance and 2 additional USB ports. J. Substantial Equivalence Information: 1. Predicate device name(s): Abaxis Piccolo Abaxis Piccolo Primary Health Panel Reagent Rotor 2. Predicate 510(k) number(s): k942782 k950164 4 3. Comparison with predicate: Assay Similarities / Differences Item Candidate Device Comprehensive Metabolic Panel k171971 Predicate Device Abaxis Piccolo Primary Health Panel Reagent Rotor k950164 Intended Use Quantitative determination of alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Same Intended users Clinical laboratories or point-of-care (POC) settings Same Specimen Type Serum and lithium-heparinized venous whole blood or plasma Same Reportable range ALT: 20 – 500 U/L ALP: 41 – 1500 U/L AST: 20 – 1000 U/L BUN: 2 – 120 mg/dL CREA: 0.6 – 20 mg/dL ALT: 5 - 2000 U/L ALP: 5 - 2400 U/L AST: 5 – 2000 U/L BUN: 2 – 180 mg/dL CREA: 0.2 - 20 mg/dL Detection Wavelength ALT: 340 nm ALP: 405 nm AST: 340 nm BUN: 340 nm CREA: 546 nm ALT: 340 - 405 nm ALP: 405 - 500 nm AST: 340 – 405 nm BUN: 340 - 405 nm CREA: 550 - 600 nm Calibration Bar-encode on each reagent disc with factory calibrated lot specific data Same Quality control Internal quality control function for each reagent disc Same Reagent storage 2-8 °C (36-45 °F) Same 5 Analyzers Similarities / Differences Item Candidate Device Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer k171971 Predicate Device Abaxis Piccolo k942782 Intended Use An in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point- of-care use. Same Detector Photodiode Same Method of measurement Colorimetry (Absorbance) Same Blood separation function Centrifugation technology integrated into the instrument Same Assay temperature 37 °C (98.6 °F) Same Test time 15 minutes 12 minutes Light Source LEDs Xenon arc stroboscopic lamp Power requirements 100-240 volts AC; 50-60 Hz; or 12 volts DC, 5.0A 100-240 volts AC; 50- 60 Hz; or 15 volts DC, 5.0 A Operating temperature 10-32 °C (50-90 °F) 15-32 °C (59-90 °F) Sample volume 200 µL 100 µL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A Evaluation of Linearity of Quantitative Measurement Procedures CLSI EP07-A2 Interference Testing in Clinical Chemistry CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance 6 L. Test Principle: ALP activity is enzymatically determined. p-Nitrophenyl phosphate that is hydrolyzed by ALP into a yellow colored product p-Nitrophenol which has an absorbance at a wavelength of 405 nm. The rate of the reaction is directly proportional to the enzyme activity. ALP p-Nitrophenyl Phosphate ────→ p-Nitrophenol + Phosphate ALT activity is enzymatically determined. ALT catalyzes the reaction of alanine with α Purpose for submission:

idK171971_s0_e2000

K171971.txt

measurand

Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measurand: Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA) D. Type of Test: Quantitative, photometric/colorimetric E. Applicant: Lite-On Technology Corp. F. Proprietary and Established Names: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer G. Regulatory Information: Regulation description Product Code Device Class Regulation Number Panel Alkaline Phosphatase test system CJE Class II 862.1050 Clinical Chemistry (75) Blood Urea Nitrogen test system CDN Class II 862.1770 Creatinine test system CGX Class II 862.1225 Aspartate aminotransferase (AST/SGOT) test system CIT Class II 862.1100 Alanine amino transferase (ALT/SGPT) test system CKA Class I 862.1030 Analyzer, chemistry, centrifugal, for clinical use JJG Class I 862.2160 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. 3. Special conditions for use statement(s): For prescription use only at point-of-care (POC) and clinical laboratory settings. 4. Special instrument requirements: skyla Clinical Chemistry Analyzer or Minicare C300 Clinical Chemistry Analyzer 3 I. Device Description: The Comprehensive Metabolic Panel contains a set of dried reagents that are used in the quantitative testing of various substances in the blood sample. The Comprehensive Metabolic Panel reagent discs are designed to separate a heparinized venous whole blood sample into plasma and blood cells, quantity the amount of plasma and diluent through the metering function of disc, mix both of plasma and diluent, and deliver the mixture to each reaction wells where the dried reagent are present to initiate the chemical reactions that are then measured by analyzer. Alternately, the disc may also be used with heparinized plasma only and serum sample. The skyla Clinical Chemistry System consists of a portable analyzer and single-use disposable reagent panel discs. The analyzers utilize precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel. The analyzer contains the following features and components: · Compatibility with lithium-heparinized venous whole blood samples without the need for sample dilution. · Operation by a colored touchscreen panel · Fully automated system for simple operation · Rapid analysis, reporting test results in approximately 15 minutes · Power-on self-test capability, ensuring instrument stability · Internal quality control functionality, ensuring reliable test results · Built-in thermal printer for immediate printing of the test results The Minicare C300 Clinical Chemistry Analyzer has the identical design and specifications of skyla Clinical Chemistry Analyzer, except the appearance and 2 additional USB ports. J. Substantial Equivalence Information: 1. Predicate device name(s): Abaxis Piccolo Abaxis Piccolo Primary Health Panel Reagent Rotor 2. Predicate 510(k) number(s): k942782 k950164 4 3. Comparison with predicate: Assay Similarities / Differences Item Candidate Device Comprehensive Metabolic Panel k171971 Predicate Device Abaxis Piccolo Primary Health Panel Reagent Rotor k950164 Intended Use Quantitative determination of alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Same Intended users Clinical laboratories or point-of-care (POC) settings Same Specimen Type Serum and lithium-heparinized venous whole blood or plasma Same Reportable range ALT: 20 – 500 U/L ALP: 41 – 1500 U/L AST: 20 – 1000 U/L BUN: 2 – 120 mg/dL CREA: 0.6 – 20 mg/dL ALT: 5 - 2000 U/L ALP: 5 - 2400 U/L AST: 5 – 2000 U/L BUN: 2 – 180 mg/dL CREA: 0.2 - 20 mg/dL Detection Wavelength ALT: 340 nm ALP: 405 nm AST: 340 nm BUN: 340 nm CREA: 546 nm ALT: 340 - 405 nm ALP: 405 - 500 nm AST: 340 – 405 nm BUN: 340 - 405 nm CREA: 550 - 600 nm Calibration Bar-encode on each reagent disc with factory calibrated lot specific data Same Quality control Internal quality control function for each reagent disc Same Reagent storage 2-8 °C (36-45 °F) Same 5 Analyzers Similarities / Differences Item Candidate Device Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer k171971 Predicate Device Abaxis Piccolo k942782 Intended Use An in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point- of-care use. Same Detector Photodiode Same Method of measurement Colorimetry (Absorbance) Same Blood separation function Centrifugation technology integrated into the instrument Same Assay temperature 37 °C (98.6 °F) Same Test time 15 minutes 12 minutes Light Source LEDs Xenon arc stroboscopic lamp Power requirements 100-240 volts AC; 50-60 Hz; or 12 volts DC, 5.0A 100-240 volts AC; 50- 60 Hz; or 15 volts DC, 5.0 A Operating temperature 10-32 °C (50-90 °F) 15-32 °C (59-90 °F) Sample volume 200 µL 100 µL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A Evaluation of Linearity of Quantitative Measurement Procedures CLSI EP07-A2 Interference Testing in Clinical Chemistry CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance 6 L. Test Principle: ALP activity is enzymatically determined. p-Nitrophenyl phosphate that is hydrolyzed by ALP into a yellow colored product p-Nitrophenol which has an absorbance at a wavelength of 405 nm. The rate of the reaction is directly proportional to the enzyme activity. ALP p-Nitrophenyl Phosphate ────→ p-Nitrophenol + Phosphate ALT activity is enzymatically determined. ALT catalyzes the reaction of alanine with α Measurand:

idK171971_s0_e2000

K171971.txt

type of test

Quantitative, photometric/colorimetric

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measurand: Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA) D. Type of Test: Quantitative, photometric/colorimetric E. Applicant: Lite-On Technology Corp. F. Proprietary and Established Names: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer G. Regulatory Information: Regulation description Product Code Device Class Regulation Number Panel Alkaline Phosphatase test system CJE Class II 862.1050 Clinical Chemistry (75) Blood Urea Nitrogen test system CDN Class II 862.1770 Creatinine test system CGX Class II 862.1225 Aspartate aminotransferase (AST/SGOT) test system CIT Class II 862.1100 Alanine amino transferase (ALT/SGPT) test system CKA Class I 862.1030 Analyzer, chemistry, centrifugal, for clinical use JJG Class I 862.2160 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. 3. Special conditions for use statement(s): For prescription use only at point-of-care (POC) and clinical laboratory settings. 4. Special instrument requirements: skyla Clinical Chemistry Analyzer or Minicare C300 Clinical Chemistry Analyzer 3 I. Device Description: The Comprehensive Metabolic Panel contains a set of dried reagents that are used in the quantitative testing of various substances in the blood sample. The Comprehensive Metabolic Panel reagent discs are designed to separate a heparinized venous whole blood sample into plasma and blood cells, quantity the amount of plasma and diluent through the metering function of disc, mix both of plasma and diluent, and deliver the mixture to each reaction wells where the dried reagent are present to initiate the chemical reactions that are then measured by analyzer. Alternately, the disc may also be used with heparinized plasma only and serum sample. The skyla Clinical Chemistry System consists of a portable analyzer and single-use disposable reagent panel discs. The analyzers utilize precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel. The analyzer contains the following features and components: · Compatibility with lithium-heparinized venous whole blood samples without the need for sample dilution. · Operation by a colored touchscreen panel · Fully automated system for simple operation · Rapid analysis, reporting test results in approximately 15 minutes · Power-on self-test capability, ensuring instrument stability · Internal quality control functionality, ensuring reliable test results · Built-in thermal printer for immediate printing of the test results The Minicare C300 Clinical Chemistry Analyzer has the identical design and specifications of skyla Clinical Chemistry Analyzer, except the appearance and 2 additional USB ports. J. Substantial Equivalence Information: 1. Predicate device name(s): Abaxis Piccolo Abaxis Piccolo Primary Health Panel Reagent Rotor 2. Predicate 510(k) number(s): k942782 k950164 4 3. Comparison with predicate: Assay Similarities / Differences Item Candidate Device Comprehensive Metabolic Panel k171971 Predicate Device Abaxis Piccolo Primary Health Panel Reagent Rotor k950164 Intended Use Quantitative determination of alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Same Intended users Clinical laboratories or point-of-care (POC) settings Same Specimen Type Serum and lithium-heparinized venous whole blood or plasma Same Reportable range ALT: 20 – 500 U/L ALP: 41 – 1500 U/L AST: 20 – 1000 U/L BUN: 2 – 120 mg/dL CREA: 0.6 – 20 mg/dL ALT: 5 - 2000 U/L ALP: 5 - 2400 U/L AST: 5 – 2000 U/L BUN: 2 – 180 mg/dL CREA: 0.2 - 20 mg/dL Detection Wavelength ALT: 340 nm ALP: 405 nm AST: 340 nm BUN: 340 nm CREA: 546 nm ALT: 340 - 405 nm ALP: 405 - 500 nm AST: 340 – 405 nm BUN: 340 - 405 nm CREA: 550 - 600 nm Calibration Bar-encode on each reagent disc with factory calibrated lot specific data Same Quality control Internal quality control function for each reagent disc Same Reagent storage 2-8 °C (36-45 °F) Same 5 Analyzers Similarities / Differences Item Candidate Device Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer k171971 Predicate Device Abaxis Piccolo k942782 Intended Use An in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point- of-care use. Same Detector Photodiode Same Method of measurement Colorimetry (Absorbance) Same Blood separation function Centrifugation technology integrated into the instrument Same Assay temperature 37 °C (98.6 °F) Same Test time 15 minutes 12 minutes Light Source LEDs Xenon arc stroboscopic lamp Power requirements 100-240 volts AC; 50-60 Hz; or 12 volts DC, 5.0A 100-240 volts AC; 50- 60 Hz; or 15 volts DC, 5.0 A Operating temperature 10-32 °C (50-90 °F) 15-32 °C (59-90 °F) Sample volume 200 µL 100 µL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A Evaluation of Linearity of Quantitative Measurement Procedures CLSI EP07-A2 Interference Testing in Clinical Chemistry CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance 6 L. Test Principle: ALP activity is enzymatically determined. p-Nitrophenyl phosphate that is hydrolyzed by ALP into a yellow colored product p-Nitrophenol which has an absorbance at a wavelength of 405 nm. The rate of the reaction is directly proportional to the enzyme activity. ALP p-Nitrophenyl Phosphate ────→ p-Nitrophenol + Phosphate ALT activity is enzymatically determined. ALT catalyzes the reaction of alanine with α Type of test:

idK171971_s0_e2000

K171971.txt

panel

Chemistry (75)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measurand: Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA) D. Type of Test: Quantitative, photometric/colorimetric E. Applicant: Lite-On Technology Corp. F. Proprietary and Established Names: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer G. Regulatory Information: Regulation description Product Code Device Class Regulation Number Panel Alkaline Phosphatase test system CJE Class II 862.1050 Clinical Chemistry (75) Blood Urea Nitrogen test system CDN Class II 862.1770 Creatinine test system CGX Class II 862.1225 Aspartate aminotransferase (AST/SGOT) test system CIT Class II 862.1100 Alanine amino transferase (ALT/SGPT) test system CKA Class I 862.1030 Analyzer, chemistry, centrifugal, for clinical use JJG Class I 862.2160 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. 3. Special conditions for use statement(s): For prescription use only at point-of-care (POC) and clinical laboratory settings. 4. Special instrument requirements: skyla Clinical Chemistry Analyzer or Minicare C300 Clinical Chemistry Analyzer 3 I. Device Description: The Comprehensive Metabolic Panel contains a set of dried reagents that are used in the quantitative testing of various substances in the blood sample. The Comprehensive Metabolic Panel reagent discs are designed to separate a heparinized venous whole blood sample into plasma and blood cells, quantity the amount of plasma and diluent through the metering function of disc, mix both of plasma and diluent, and deliver the mixture to each reaction wells where the dried reagent are present to initiate the chemical reactions that are then measured by analyzer. Alternately, the disc may also be used with heparinized plasma only and serum sample. The skyla Clinical Chemistry System consists of a portable analyzer and single-use disposable reagent panel discs. The analyzers utilize precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel. The analyzer contains the following features and components: · Compatibility with lithium-heparinized venous whole blood samples without the need for sample dilution. · Operation by a colored touchscreen panel · Fully automated system for simple operation · Rapid analysis, reporting test results in approximately 15 minutes · Power-on self-test capability, ensuring instrument stability · Internal quality control functionality, ensuring reliable test results · Built-in thermal printer for immediate printing of the test results The Minicare C300 Clinical Chemistry Analyzer has the identical design and specifications of skyla Clinical Chemistry Analyzer, except the appearance and 2 additional USB ports. J. Substantial Equivalence Information: 1. Predicate device name(s): Abaxis Piccolo Abaxis Piccolo Primary Health Panel Reagent Rotor 2. Predicate 510(k) number(s): k942782 k950164 4 3. Comparison with predicate: Assay Similarities / Differences Item Candidate Device Comprehensive Metabolic Panel k171971 Predicate Device Abaxis Piccolo Primary Health Panel Reagent Rotor k950164 Intended Use Quantitative determination of alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Same Intended users Clinical laboratories or point-of-care (POC) settings Same Specimen Type Serum and lithium-heparinized venous whole blood or plasma Same Reportable range ALT: 20 – 500 U/L ALP: 41 – 1500 U/L AST: 20 – 1000 U/L BUN: 2 – 120 mg/dL CREA: 0.6 – 20 mg/dL ALT: 5 - 2000 U/L ALP: 5 - 2400 U/L AST: 5 – 2000 U/L BUN: 2 – 180 mg/dL CREA: 0.2 - 20 mg/dL Detection Wavelength ALT: 340 nm ALP: 405 nm AST: 340 nm BUN: 340 nm CREA: 546 nm ALT: 340 - 405 nm ALP: 405 - 500 nm AST: 340 – 405 nm BUN: 340 - 405 nm CREA: 550 - 600 nm Calibration Bar-encode on each reagent disc with factory calibrated lot specific data Same Quality control Internal quality control function for each reagent disc Same Reagent storage 2-8 °C (36-45 °F) Same 5 Analyzers Similarities / Differences Item Candidate Device Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer k171971 Predicate Device Abaxis Piccolo k942782 Intended Use An in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point- of-care use. Same Detector Photodiode Same Method of measurement Colorimetry (Absorbance) Same Blood separation function Centrifugation technology integrated into the instrument Same Assay temperature 37 °C (98.6 °F) Same Test time 15 minutes 12 minutes Light Source LEDs Xenon arc stroboscopic lamp Power requirements 100-240 volts AC; 50-60 Hz; or 12 volts DC, 5.0A 100-240 volts AC; 50- 60 Hz; or 15 volts DC, 5.0 A Operating temperature 10-32 °C (50-90 °F) 15-32 °C (59-90 °F) Sample volume 200 µL 100 µL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A Evaluation of Linearity of Quantitative Measurement Procedures CLSI EP07-A2 Interference Testing in Clinical Chemistry CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance 6 L. Test Principle: ALP activity is enzymatically determined. p-Nitrophenyl phosphate that is hydrolyzed by ALP into a yellow colored product p-Nitrophenol which has an absorbance at a wavelength of 405 nm. The rate of the reaction is directly proportional to the enzyme activity. ALP p-Nitrophenyl Phosphate ────→ p-Nitrophenol + Phosphate ALT activity is enzymatically determined. ALT catalyzes the reaction of alanine with α Panel:

idK171971_s0_e2000

K171971.txt

intended use

See Indications for use below

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measurand: Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA) D. Type of Test: Quantitative, photometric/colorimetric E. Applicant: Lite-On Technology Corp. F. Proprietary and Established Names: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer G. Regulatory Information: Regulation description Product Code Device Class Regulation Number Panel Alkaline Phosphatase test system CJE Class II 862.1050 Clinical Chemistry (75) Blood Urea Nitrogen test system CDN Class II 862.1770 Creatinine test system CGX Class II 862.1225 Aspartate aminotransferase (AST/SGOT) test system CIT Class II 862.1100 Alanine amino transferase (ALT/SGPT) test system CKA Class I 862.1030 Analyzer, chemistry, centrifugal, for clinical use JJG Class I 862.2160 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. 3. Special conditions for use statement(s): For prescription use only at point-of-care (POC) and clinical laboratory settings. 4. Special instrument requirements: skyla Clinical Chemistry Analyzer or Minicare C300 Clinical Chemistry Analyzer 3 I. Device Description: The Comprehensive Metabolic Panel contains a set of dried reagents that are used in the quantitative testing of various substances in the blood sample. The Comprehensive Metabolic Panel reagent discs are designed to separate a heparinized venous whole blood sample into plasma and blood cells, quantity the amount of plasma and diluent through the metering function of disc, mix both of plasma and diluent, and deliver the mixture to each reaction wells where the dried reagent are present to initiate the chemical reactions that are then measured by analyzer. Alternately, the disc may also be used with heparinized plasma only and serum sample. The skyla Clinical Chemistry System consists of a portable analyzer and single-use disposable reagent panel discs. The analyzers utilize precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel. The analyzer contains the following features and components: · Compatibility with lithium-heparinized venous whole blood samples without the need for sample dilution. · Operation by a colored touchscreen panel · Fully automated system for simple operation · Rapid analysis, reporting test results in approximately 15 minutes · Power-on self-test capability, ensuring instrument stability · Internal quality control functionality, ensuring reliable test results · Built-in thermal printer for immediate printing of the test results The Minicare C300 Clinical Chemistry Analyzer has the identical design and specifications of skyla Clinical Chemistry Analyzer, except the appearance and 2 additional USB ports. J. Substantial Equivalence Information: 1. Predicate device name(s): Abaxis Piccolo Abaxis Piccolo Primary Health Panel Reagent Rotor 2. Predicate 510(k) number(s): k942782 k950164 4 3. Comparison with predicate: Assay Similarities / Differences Item Candidate Device Comprehensive Metabolic Panel k171971 Predicate Device Abaxis Piccolo Primary Health Panel Reagent Rotor k950164 Intended Use Quantitative determination of alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Same Intended users Clinical laboratories or point-of-care (POC) settings Same Specimen Type Serum and lithium-heparinized venous whole blood or plasma Same Reportable range ALT: 20 – 500 U/L ALP: 41 – 1500 U/L AST: 20 – 1000 U/L BUN: 2 – 120 mg/dL CREA: 0.6 – 20 mg/dL ALT: 5 - 2000 U/L ALP: 5 - 2400 U/L AST: 5 – 2000 U/L BUN: 2 – 180 mg/dL CREA: 0.2 - 20 mg/dL Detection Wavelength ALT: 340 nm ALP: 405 nm AST: 340 nm BUN: 340 nm CREA: 546 nm ALT: 340 - 405 nm ALP: 405 - 500 nm AST: 340 – 405 nm BUN: 340 - 405 nm CREA: 550 - 600 nm Calibration Bar-encode on each reagent disc with factory calibrated lot specific data Same Quality control Internal quality control function for each reagent disc Same Reagent storage 2-8 °C (36-45 °F) Same 5 Analyzers Similarities / Differences Item Candidate Device Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer k171971 Predicate Device Abaxis Piccolo k942782 Intended Use An in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point- of-care use. Same Detector Photodiode Same Method of measurement Colorimetry (Absorbance) Same Blood separation function Centrifugation technology integrated into the instrument Same Assay temperature 37 °C (98.6 °F) Same Test time 15 minutes 12 minutes Light Source LEDs Xenon arc stroboscopic lamp Power requirements 100-240 volts AC; 50-60 Hz; or 12 volts DC, 5.0A 100-240 volts AC; 50- 60 Hz; or 15 volts DC, 5.0 A Operating temperature 10-32 °C (50-90 °F) 15-32 °C (59-90 °F) Sample volume 200 µL 100 µL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A Evaluation of Linearity of Quantitative Measurement Procedures CLSI EP07-A2 Interference Testing in Clinical Chemistry CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance 6 L. Test Principle: ALP activity is enzymatically determined. p-Nitrophenyl phosphate that is hydrolyzed by ALP into a yellow colored product p-Nitrophenol which has an absorbance at a wavelength of 405 nm. The rate of the reaction is directly proportional to the enzyme activity. ALP p-Nitrophenyl Phosphate ────→ p-Nitrophenol + Phosphate ALT activity is enzymatically determined. ALT catalyzes the reaction of alanine with α Intended use:

idK171971_s0_e2000

K171971.txt

indications for use

The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measurand: Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA) D. Type of Test: Quantitative, photometric/colorimetric E. Applicant: Lite-On Technology Corp. F. Proprietary and Established Names: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer G. Regulatory Information: Regulation description Product Code Device Class Regulation Number Panel Alkaline Phosphatase test system CJE Class II 862.1050 Clinical Chemistry (75) Blood Urea Nitrogen test system CDN Class II 862.1770 Creatinine test system CGX Class II 862.1225 Aspartate aminotransferase (AST/SGOT) test system CIT Class II 862.1100 Alanine amino transferase (ALT/SGPT) test system CKA Class I 862.1030 Analyzer, chemistry, centrifugal, for clinical use JJG Class I 862.2160 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. 3. Special conditions for use statement(s): For prescription use only at point-of-care (POC) and clinical laboratory settings. 4. Special instrument requirements: skyla Clinical Chemistry Analyzer or Minicare C300 Clinical Chemistry Analyzer 3 I. Device Description: The Comprehensive Metabolic Panel contains a set of dried reagents that are used in the quantitative testing of various substances in the blood sample. The Comprehensive Metabolic Panel reagent discs are designed to separate a heparinized venous whole blood sample into plasma and blood cells, quantity the amount of plasma and diluent through the metering function of disc, mix both of plasma and diluent, and deliver the mixture to each reaction wells where the dried reagent are present to initiate the chemical reactions that are then measured by analyzer. Alternately, the disc may also be used with heparinized plasma only and serum sample. The skyla Clinical Chemistry System consists of a portable analyzer and single-use disposable reagent panel discs. The analyzers utilize precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel. The analyzer contains the following features and components: · Compatibility with lithium-heparinized venous whole blood samples without the need for sample dilution. · Operation by a colored touchscreen panel · Fully automated system for simple operation · Rapid analysis, reporting test results in approximately 15 minutes · Power-on self-test capability, ensuring instrument stability · Internal quality control functionality, ensuring reliable test results · Built-in thermal printer for immediate printing of the test results The Minicare C300 Clinical Chemistry Analyzer has the identical design and specifications of skyla Clinical Chemistry Analyzer, except the appearance and 2 additional USB ports. J. Substantial Equivalence Information: 1. Predicate device name(s): Abaxis Piccolo Abaxis Piccolo Primary Health Panel Reagent Rotor 2. Predicate 510(k) number(s): k942782 k950164 4 3. Comparison with predicate: Assay Similarities / Differences Item Candidate Device Comprehensive Metabolic Panel k171971 Predicate Device Abaxis Piccolo Primary Health Panel Reagent Rotor k950164 Intended Use Quantitative determination of alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Same Intended users Clinical laboratories or point-of-care (POC) settings Same Specimen Type Serum and lithium-heparinized venous whole blood or plasma Same Reportable range ALT: 20 – 500 U/L ALP: 41 – 1500 U/L AST: 20 – 1000 U/L BUN: 2 – 120 mg/dL CREA: 0.6 – 20 mg/dL ALT: 5 - 2000 U/L ALP: 5 - 2400 U/L AST: 5 – 2000 U/L BUN: 2 – 180 mg/dL CREA: 0.2 - 20 mg/dL Detection Wavelength ALT: 340 nm ALP: 405 nm AST: 340 nm BUN: 340 nm CREA: 546 nm ALT: 340 - 405 nm ALP: 405 - 500 nm AST: 340 – 405 nm BUN: 340 - 405 nm CREA: 550 - 600 nm Calibration Bar-encode on each reagent disc with factory calibrated lot specific data Same Quality control Internal quality control function for each reagent disc Same Reagent storage 2-8 °C (36-45 °F) Same 5 Analyzers Similarities / Differences Item Candidate Device Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer k171971 Predicate Device Abaxis Piccolo k942782 Intended Use An in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point- of-care use. Same Detector Photodiode Same Method of measurement Colorimetry (Absorbance) Same Blood separation function Centrifugation technology integrated into the instrument Same Assay temperature 37 °C (98.6 °F) Same Test time 15 minutes 12 minutes Light Source LEDs Xenon arc stroboscopic lamp Power requirements 100-240 volts AC; 50-60 Hz; or 12 volts DC, 5.0A 100-240 volts AC; 50- 60 Hz; or 15 volts DC, 5.0 A Operating temperature 10-32 °C (50-90 °F) 15-32 °C (59-90 °F) Sample volume 200 µL 100 µL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A Evaluation of Linearity of Quantitative Measurement Procedures CLSI EP07-A2 Interference Testing in Clinical Chemistry CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance 6 L. Test Principle: ALP activity is enzymatically determined. p-Nitrophenyl phosphate that is hydrolyzed by ALP into a yellow colored product p-Nitrophenol which has an absorbance at a wavelength of 405 nm. The rate of the reaction is directly proportional to the enzyme activity. ALP p-Nitrophenyl Phosphate ────→ p-Nitrophenol + Phosphate ALT activity is enzymatically determined. ALT catalyzes the reaction of alanine with α Indications for use:

idK171971_s0_e2000

K171971.txt

applicant

Lite-On Technology Corp.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measurand: Alkaline phosphate (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Blood urea nitrogen (BUN) and Creatinine (CREA) D. Type of Test: Quantitative, photometric/colorimetric E. Applicant: Lite-On Technology Corp. F. Proprietary and Established Names: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer G. Regulatory Information: Regulation description Product Code Device Class Regulation Number Panel Alkaline Phosphatase test system CJE Class II 862.1050 Clinical Chemistry (75) Blood Urea Nitrogen test system CDN Class II 862.1770 Creatinine test system CGX Class II 862.1225 Aspartate aminotransferase (AST/SGOT) test system CIT Class II 862.1100 Alanine amino transferase (ALT/SGPT) test system CKA Class I 862.1030 Analyzer, chemistry, centrifugal, for clinical use JJG Class I 862.2160 2 H. Intended Use: 1. Intended use(s): See Indications for use below 2. Indication(s) for use: The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. The Minicare C300 Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use. 3. Special conditions for use statement(s): For prescription use only at point-of-care (POC) and clinical laboratory settings. 4. Special instrument requirements: skyla Clinical Chemistry Analyzer or Minicare C300 Clinical Chemistry Analyzer 3 I. Device Description: The Comprehensive Metabolic Panel contains a set of dried reagents that are used in the quantitative testing of various substances in the blood sample. The Comprehensive Metabolic Panel reagent discs are designed to separate a heparinized venous whole blood sample into plasma and blood cells, quantity the amount of plasma and diluent through the metering function of disc, mix both of plasma and diluent, and deliver the mixture to each reaction wells where the dried reagent are present to initiate the chemical reactions that are then measured by analyzer. Alternately, the disc may also be used with heparinized plasma only and serum sample. The skyla Clinical Chemistry System consists of a portable analyzer and single-use disposable reagent panel discs. The analyzers utilize precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel. The analyzer contains the following features and components: · Compatibility with lithium-heparinized venous whole blood samples without the need for sample dilution. · Operation by a colored touchscreen panel · Fully automated system for simple operation · Rapid analysis, reporting test results in approximately 15 minutes · Power-on self-test capability, ensuring instrument stability · Internal quality control functionality, ensuring reliable test results · Built-in thermal printer for immediate printing of the test results The Minicare C300 Clinical Chemistry Analyzer has the identical design and specifications of skyla Clinical Chemistry Analyzer, except the appearance and 2 additional USB ports. J. Substantial Equivalence Information: 1. Predicate device name(s): Abaxis Piccolo Abaxis Piccolo Primary Health Panel Reagent Rotor 2. Predicate 510(k) number(s): k942782 k950164 4 3. Comparison with predicate: Assay Similarities / Differences Item Candidate Device Comprehensive Metabolic Panel k171971 Predicate Device Abaxis Piccolo Primary Health Panel Reagent Rotor k950164 Intended Use Quantitative determination of alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Same Intended users Clinical laboratories or point-of-care (POC) settings Same Specimen Type Serum and lithium-heparinized venous whole blood or plasma Same Reportable range ALT: 20 – 500 U/L ALP: 41 – 1500 U/L AST: 20 – 1000 U/L BUN: 2 – 120 mg/dL CREA: 0.6 – 20 mg/dL ALT: 5 - 2000 U/L ALP: 5 - 2400 U/L AST: 5 – 2000 U/L BUN: 2 – 180 mg/dL CREA: 0.2 - 20 mg/dL Detection Wavelength ALT: 340 nm ALP: 405 nm AST: 340 nm BUN: 340 nm CREA: 546 nm ALT: 340 - 405 nm ALP: 405 - 500 nm AST: 340 – 405 nm BUN: 340 - 405 nm CREA: 550 - 600 nm Calibration Bar-encode on each reagent disc with factory calibrated lot specific data Same Quality control Internal quality control function for each reagent disc Same Reagent storage 2-8 °C (36-45 °F) Same 5 Analyzers Similarities / Differences Item Candidate Device Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer k171971 Predicate Device Abaxis Piccolo k942782 Intended Use An in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point- of-care use. Same Detector Photodiode Same Method of measurement Colorimetry (Absorbance) Same Blood separation function Centrifugation technology integrated into the instrument Same Assay temperature 37 °C (98.6 °F) Same Test time 15 minutes 12 minutes Light Source LEDs Xenon arc stroboscopic lamp Power requirements 100-240 volts AC; 50-60 Hz; or 12 volts DC, 5.0A 100-240 volts AC; 50- 60 Hz; or 15 volts DC, 5.0 A Operating temperature 10-32 °C (50-90 °F) 15-32 °C (59-90 °F) Sample volume 200 µL 100 µL K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A Evaluation of Linearity of Quantitative Measurement Procedures CLSI EP07-A2 Interference Testing in Clinical Chemistry CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance 6 L. Test Principle: ALP activity is enzymatically determined. p-Nitrophenyl phosphate that is hydrolyzed by ALP into a yellow colored product p-Nitrophenol which has an absorbance at a wavelength of 405 nm. The rate of the reaction is directly proportional to the enzyme activity. ALP p-Nitrophenyl Phosphate ────→ p-Nitrophenol + Phosphate ALT activity is enzymatically determined. ALT catalyzes the reaction of alanine with α Applicant:

idK171971_s8000_e10000

K171971.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

0.9989 7.7-90.2 WB vs. Serum 0.982 0.71 0.9990 7.8-91.7 CREA (mg/dL) Serum vs. Plasma 0.960 0.13 0.9965 0.7-19.3 WB vs. Serum 1.004 -0.02 0.9971 0.6-19.8 16 The results of the matrix comparison study support the sponsor claim that serum, lithium heparin plasma and venous lithium heparin whole blood samples can be tested with these assays. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: The following expected values are provided in the product insert based on the literature1: Analyte Reference range Reference range (SI units) ALP 37 – 108 U/L 37 – 108 U/L ALT 10 - 40 U/L 10 - 40 U/L AST 10 – 42 U/L 10 – 42 U/L BUN 9 – 23 mg/dL 3.2 – 8.2 mmol urea/L Creatinine Male 0.7 – 1.3 mg/dL 62 – 115 µmol/L Female 0.6 – 1.1 mg/dL 53 – 97 µmol/L 1C. A. Burtis, E. R. Ashwood, and D. E. Bruns. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed., Elsevier Saunders, St. Louis, 2006 N. Instrument Name: skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer 17 O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes X or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes _______ or No X 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes X or No ________ 3. Specimen Identification: The user can utilize an external barcode scanner or touch screen display to manually enter patient information. 4. Specimen Sampling and Handling: The following type of sampling devices are acceptable on the Skyla Chemistry Clinical Chemistry Analyzer and Minicare C300 Clinical Chemistry Analyzer: · lithium-heparinized venous whole blood · heparinized plasma · serum 5. Calibration: The Analyzer performs automatic system calibrations every time the instrument is powered on. The barcode on every manufactured reagent disc contains all information required for calibration of the test items. The analyzer will automatically read the barcode information during testing. 18 6. Quality Control: The sponsor recommends using BIO-RAD Lyphochek Assayed Chemistry Control / two levels (Level 1 and Level 2). The following recommendations are included in package insert: · Quality control should be performed on each day the instrument is used. · Users should follow local, state and federal regulations for quality control materials testing. · Quality control should be analyzed when a new lot of discs are used on the analyzer. · Quality control should be performed after analyzer has been turned off for any reason or reinitializing the analyzer. · Quality control should be performed after routine maintenance procedures. · Before a new batch of reagents is used for testing. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK171971_s8000_e10000

K171971.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

.45 0.9989 7.7-90.2 WB vs. Serum 0.982 0.71 0.9990 7.8-91.7 CREA (mg/dL) Serum vs. Plasma 0.960 0.13 0.9965 0.7-19.3 WB vs. Serum 1.004 -0.02 0.9971 0.6-19.8 16 The results of the matrix comparison study support the sponsor claim that serum, lithium heparin plasma and venous lithium heparin whole blood samples can be tested with these assays. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: The following expected values are provided in the product insert based on the literature1: Analyte Reference range Reference range (SI units) ALP 37 – 108 U/L 37 – 108 U/L ALT 10 - 40 U/L 10 - 40 U/L AST 10 – 42 U/L 10 – 42 U/L BUN 9 – 23 mg/dL 3.2 – 8.2 mmol urea/L Creatinine Male 0.7 – 1.3 mg/dL 62 – 115 µmol/L Female 0.6 – 1.1 mg/dL 53 – 97 µmol/L 1C. A. Burtis, E. R. Ashwood, and D. E. Bruns. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed., Elsevier Saunders, St. Louis, 2006 N. Instrument Name: skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer 17 O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes X or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes _______ or No X 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes X or No ________ 3. Specimen Identification: The user can utilize an external barcode scanner or touch screen display to manually enter patient information. 4. Specimen Sampling and Handling: The following type of sampling devices are acceptable on the Skyla Chemistry Clinical Chemistry Analyzer and Minicare C300 Clinical Chemistry Analyzer: · lithium-heparinized venous whole blood · heparinized plasma · serum 5. Calibration: The Analyzer performs automatic system calibrations every time the instrument is powered on. The barcode on every manufactured reagent disc contains all information required for calibration of the test items. The analyzer will automatically read the barcode information during testing. 18 6. Quality Control: The sponsor recommends using BIO-RAD Lyphochek Assayed Chemistry Control / two levels (Level 1 and Level 2). The following recommendations are included in package insert: · Quality control should be performed on each day the instrument is used. · Users should follow local, state and federal regulations for quality control materials testing. · Quality control should be analyzed when a new lot of discs are used on the analyzer. · Quality control should be performed after analyzer has been turned off for any reason or reinitializing the analyzer. · Quality control should be performed after routine maintenance procedures. · Before a new batch of reagents is used for testing. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not applicable. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK171641_s0_e2000

K171641.txt

purpose for submission

This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Purpose for submission:

idK171641_s0_e2000

K171641.txt

measurand

Influenza A PB2 RNA Influenza B Matrix RNA

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Measurand:

idK171641_s0_e2000

K171641.txt

type of test

RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Type of test:

idK171641_s0_e2000

K171641.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Classification:

idK171641_s0_e2000

K171641.txt

product code

OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Product code:

idK171641_s0_e2000

K171641.txt

panel

Microbiology (83)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Panel:

idK171641_s0_e2000

K171641.txt

intended use

The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Intended use:

idK171641_s0_e2000

K171641.txt

predicate device name

Alere i Influenza A&B

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Predicate device name:

idK171641_s0_e2000

K171641.txt

applicant

Mesa Biotech, Inc.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Applicant:

idK171641_s0_e2000

K171641.txt

proprietary and established names

Accula Flu A/Flu B Test

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Proprietary and established names:

idK171641_s0_e2000

K171641.txt

regulation section

21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K171641 B. Purpose for Submission: This is a new 510(k) application for the determination of Substantial Equivalence for the Mesa Biotech Accula Flu A/Flu B Test and associated instrument. Mesa Biotech, Inc. has submited a combined 510(k) and CLIA waiver package for dual review. C. Measurand: Influenza A PB2 RNA Influenza B Matrix RNA D. Type of Test: RT-PCR amplification followed by hybridization and colorimetric visualization of amplified products on a test strip E. Applicant: Mesa Biotech, Inc. F. Proprietary and Established Names: Accula Flu A/Flu B Test G. Regulatory Information: 1. Regulation section: 21 CRF 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZE - Influenza A and Influenza B Multiplex Nucleic Acid Assay 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For Prescription Use 4. Special instrument requirements: To be used only with the Accula Dock Instrument I. Device Description: The Accula Flu A/Flu B Test is a semi-automated, colorimetric, multiplex reverse- 3 transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect influenza A and B viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, amplification using a novel Mesa Biotech technology, and hybridization-based visual detection into a completely self-contained and automated system. The Accula Flu A/Flu B system consists of a small reusable Dock to drive the automated testing process and a single-use disposable test cassette that contains all the enzymes and reagents. Upon insertion of a Test Cassette, the Dock will detect and identify the cassette type. After the user transfers a clinical sample into the cassette and closes the dock lid, the embedded firmware will control fluid flow of the sample into the various chambers of the cassette. Amplicon detection requires the hybridization of two internal probes to generate a signal on the Accula Flu A/Flu B detection strip. Dyed polystyrene microspheres are conjugated to oligonucleotide probes to form an amplicon-microsphere complex by hybridization to an internal region of the amplicon. The complex migrates through the pores of the detection strip membrane and across capture zones which contain oligonucleotides complementary to an amplicon region distinct from the detection probe binding site. Hybridization of the amplicon-microsphere complex to a capture zone probe retards the flow of the specific amplicon and results in the generation of a visible signal in the form of a colored line. Interpretation of results: Results are interpreted visually by the operator after the test has completed. A colored line of any intensity at the “Flu A” and/or “Flu B” location indicates a positive result for that influenza virus type if the test is valid. A Negative Control line at the end of the test strip controls for non-specific binding or amplification and must be absent for a valid test. A control line at the beginning of the strip displays amplification effectiveness and is necessary to interpret a test as “negative” for influenza A and influenza B. J. Substantial Equivalence Information: 1. Predicate device name(s): Alere i Influenza A&B 2. Predicate 510(k) number(s): K141520 3. Comparison with predicate: 4 Table 1: Similarities Between Accula Flu A/Flu B and Predicate Device Similarities Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Assay Targets Influenza A and Influenza B virus Same Sample Type Nasal Swab Same Assay Results Qualitative Same Intended Users and Locations Clinical Lab and Point of Care Same Nucleic Acid Purification No Same Influenza A Target PB2 Gene Same Internal Control Yes Same Positive and Negative Control Swabs Yes Same Table 2: Differences Between Accula Flu A/Flu B and Predicate Device Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test Intended Use The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. 5 Differences Item Mesa Biotech Accula Flu A/Flu B Test Alere i Influenza A&B Test basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local public health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Performance characteristics for influenza A were established during the 2012-2013 influenza season when influenza A/H3 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Influenza B Target Matrix Gene PA Gene Assay Technology PCR amplification and visual identification of amplified products by hybridization to a test strip Isothermal nucleic acid amplification and detection of amplified products using molecular beacon probes Detection Dyed microparticle conjugates specifically detect amplified products Fluorescently-labeled molecular beacons identify amplified RNA targets Instrument Amplification controlled by the Accula Dock Amplification performed on the Alere i Instrument Results Interpretation Visual interpretation of colored lines on a test strip Optical detection of fluorescence by the Alere i instrument 6 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: Nucleic acid amplification plus hybridization to a membrane and chromatographic visual detection M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The reproducibility of the Accula Flu A/Flu B Test was tested in a study using contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United Regulation section:

idK171641_s6000_e8000

K171641.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

Group (Years) Female Male Total ˂5 230 258 488 6-21 279 322 601 22-59 78 49 127 ≥60 26 16 42 Total 613 645 1258 During the prospective clinical study, the initial invalid rate for nasal swab samples (before repeat testing per the product instructions) was 9.1% (116/1272). After repeat testing per the product instructions, the invalid rate was 1.1% (14/1272). Performance of the Accula Flu A/Flu B assay compared to an FDA-cleared molecular assay for nasal swab samples is presented below. Table 10: Accula Flu A/Flu B Influenza A Performance Compared to FDA-cleared Molecular Comparator. Accula Flu A/Flu B Comparator Positive Negative Total Positive 289 60a 349 Negative 9b 900 909 Total 298 960 1258 Sensitivity: 97% (95% CI: 94.4-98.4%) Specificity: 94% (95% CI: 92.0-95.1%) a Flu Awas detected in 47/60 false positive specimens using an alternative FDA-cleared molecular influenza assay. b Flu B was not detected in 3/9 false negative specimens using an alternative FDA-cleared molecular influenza assay. 14 Table 11: Accula Flu A/Flu B Influenza B Performance Compared to FDA-cleared Molecular Comparator. Accula Flu A/Flu B Comparator Positive Negative Total Positive 126 14a 140 Negative 8 b 1110 1118 Total 134 1124 1258 Sensitivity: 94% (95% CI: 88.7-97.0%) Specificity: 99% (95% CI: 97.9-99.3%) a Flu A was detected in 9/14 false positive specimens using an alternative FDA-cleared molecular influenza assay. b Flu B was not detected in 5/8 false negative specimens using an alternative FDA-cleared molecular influenza assay. 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: In the Accula Flu A/Flu B clinical study (described in the “Clinical Studies” section above), a total of 1258 nasal swab specimens were evaluable by the Accula Flu A/Flu B assay. The number and percentage of influenza A and influenza B positive cases per specified age group, as determined by the Accula Flu A/Flu B assay, are presented in the tables below: Table 12: Influenza A Expected Values Age Group (Years) Number of Specimens Number of Influenza A Positives Influenza A Positivity Rate ˂5 488 97 19.9% 6-21 601 172 28.6% ≥22 169 20 11.8% Total 1258 289 23.0% Table 13: Influenza B Expected Values Age Group (Years) Number of Specimens Number of Influenza B Positives Influenza B Positivity Rate ˂5 488 27 5.5% 6-21 601 91 15.1% ≥22 169 8 4.7% Total 1258 126 10.0% 15 N. Instrument Name: Accula Dock O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ________ or No ___X____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X____ or No ________ 3. Specimen Identification: Specimen ID is entered by hand directly onto the test cassette. 4. Specimen Sampling and Handling: Not applicable. The specimens are manually inserted into the test cassette in the instrument. 5. Calibration: The Accula Dock is factory calibrated and does not require any further calibration at the user site. 6. Quality Control: Quality control is addressed for each specific FDA-cleared assay to be run on the instrument (separately cleared). 16 P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: N/A Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK171641_s6000_e8000

K171641.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Distribution Age Group (Years) Female Male Total ˂5 230 258 488 6-21 279 322 601 22-59 78 49 127 ≥60 26 16 42 Total 613 645 1258 During the prospective clinical study, the initial invalid rate for nasal swab samples (before repeat testing per the product instructions) was 9.1% (116/1272). After repeat testing per the product instructions, the invalid rate was 1.1% (14/1272). Performance of the Accula Flu A/Flu B assay compared to an FDA-cleared molecular assay for nasal swab samples is presented below. Table 10: Accula Flu A/Flu B Influenza A Performance Compared to FDA-cleared Molecular Comparator. Accula Flu A/Flu B Comparator Positive Negative Total Positive 289 60a 349 Negative 9b 900 909 Total 298 960 1258 Sensitivity: 97% (95% CI: 94.4-98.4%) Specificity: 94% (95% CI: 92.0-95.1%) a Flu Awas detected in 47/60 false positive specimens using an alternative FDA-cleared molecular influenza assay. b Flu B was not detected in 3/9 false negative specimens using an alternative FDA-cleared molecular influenza assay. 14 Table 11: Accula Flu A/Flu B Influenza B Performance Compared to FDA-cleared Molecular Comparator. Accula Flu A/Flu B Comparator Positive Negative Total Positive 126 14a 140 Negative 8 b 1110 1118 Total 134 1124 1258 Sensitivity: 94% (95% CI: 88.7-97.0%) Specificity: 99% (95% CI: 97.9-99.3%) a Flu A was detected in 9/14 false positive specimens using an alternative FDA-cleared molecular influenza assay. b Flu B was not detected in 5/8 false negative specimens using an alternative FDA-cleared molecular influenza assay. 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: In the Accula Flu A/Flu B clinical study (described in the “Clinical Studies” section above), a total of 1258 nasal swab specimens were evaluable by the Accula Flu A/Flu B assay. The number and percentage of influenza A and influenza B positive cases per specified age group, as determined by the Accula Flu A/Flu B assay, are presented in the tables below: Table 12: Influenza A Expected Values Age Group (Years) Number of Specimens Number of Influenza A Positives Influenza A Positivity Rate ˂5 488 97 19.9% 6-21 601 172 28.6% ≥22 169 20 11.8% Total 1258 289 23.0% Table 13: Influenza B Expected Values Age Group (Years) Number of Specimens Number of Influenza B Positives Influenza B Positivity Rate ˂5 488 27 5.5% 6-21 601 91 15.1% ≥22 169 8 4.7% Total 1258 126 10.0% 15 N. Instrument Name: Accula Dock O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ________ or No ___X____ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X____ or No ________ 3. Specimen Identification: Specimen ID is entered by hand directly onto the test cassette. 4. Specimen Sampling and Handling: Not applicable. The specimens are manually inserted into the test cassette in the instrument. 5. Calibration: The Accula Dock is factory calibrated and does not require any further calibration at the user site. 6. Quality Control: Quality control is addressed for each specific FDA-cleared assay to be run on the instrument (separately cleared). 16 P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: N/A Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK180559_s0_e2000

K180559.txt

purpose for submission

Clearance of New Device.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Purpose for submission:

idK180559_s0_e2000

K180559.txt

measurand

Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Measurand:

idK180559_s0_e2000

K180559.txt

type of test

Qualitative Real-Time PCR Assay

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Type of test:

idK180559_s0_e2000

K180559.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Classification:

idK180559_s0_e2000

K180559.txt

product code

PGI

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Product code:

idK180559_s0_e2000

K180559.txt

panel

83 - Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Panel:

idK180559_s0_e2000

K180559.txt

indications for use

Same as intended use.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Indications for use:

idK180559_s0_e2000

K180559.txt

predicate device name

ARIES® HSV 1&2 Assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Predicate device name:

idK180559_s0_e2000

K180559.txt

applicant

ELITechGroup Inc. Molecular Diagnostics

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Applicant:

idK180559_s0_e2000

K180559.txt

proprietary and established names

HSV 1&2 ELITe MBG Assay

ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Proprietary and established names:

idK180559_s0_e2000

K180559.txt

regulation section

21CFR 866.3309

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K180559 B. Purpose for Submission: Clearance of New Device. C. Measurand: Target DNA Sequences from conserved regions of Herpes Simplex Virus Type 1 (HSV- 1) and Herpes Simplex Virus Type 2 (HSV- 2) D. Type of Test: Qualitative Real-Time PCR Assay E. Applicant: ELITechGroup Inc. Molecular Diagnostics F. Proprietary and Established Names: HSV 1&2 ELITe MBG Assay G. Regulatory Information: 1. Regulation section: 21CFR 866.3309 2. Classification: Class II 3. Product code: PGI 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: The HSV 1&2 ELITe MGB Assay is indicated for use on the ELITe InGenius ® System. I. Device Description: The HSV 1&2 ELITe MGB Assay is a multiplexed qualitative in vitro diagnostic Real-Time PCR Assay that uses unique primer sets and single uniquely labeled probes to amplify and detect: • The Herpes Simplex Virus (HSV) genotype 1; HSV-1 glycoprotein D encoding gene, • The HSV-2 glycoprotein G encoding gene, and • An Internal Control. Intended for the direct detection of HSV DNA in symptomatic male and female patients using DNA purified from swab specimens collected from cutaneous or mucocutaneous lesions from individuals with herpetic lesions. The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagents and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The unused eluates can be saved for future retesting or archiving. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): ARIES® HSV 1&2 Assay 2. Predicate 510(k) number(s): K151906 3. Comparison with predicate: Similarities Item Device Predicate Indications For Use The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV- 1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV- 2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products. The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening. Extraction Technology Same as predicate Automated Amplification Technology Same as predicate Qualitative Real-time PCR Samples Type Same as predicate Male and female cutaneous and mucocutaneous lesion swab samples 4 Differences Item Device Predicate Assay Targets DNA sequences from HSV-1 glycoprotein D gene and HSV-2 glycoprotein G gene. DNA sequences from Herpes Simplex Virus type 1 (HSV- 1) and Herpes Simplex Virus type 2 (HSV-2)- different target Detection Technology Multiplex assay with paired reporter and quencher fluorescence labeled probes and different reporter dyes for each target. Measures increase in assay fluorescence with each PCR cycle. Pairs fluorescent-labeled primers with quencher labeled nucleotides. Measures decrease in assay fluorescence with each PCR cycle. K. Standard/Guidance Document Referenced (if applicable): 1. Evaluating Substantial Equivalence in Premarket Notifications 510(k) 2. Statistical Guidance on Reporting Results from studies evaluating diagnostic tests 3. Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (DRAFT 10-2-14) 4. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection 5. Guidance for Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (1500626) (09-12-17) 6. Guidance for Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 7. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices 8. Guidance for Refuse to Accept Policy for 510(k)s 9. EP05-A3 Vol. 34 No. 13 - Evaluation of Precision Performance of Quantitative 10. Measurement Methods; Approved Guideline-Third Edition 11. EP12-A2 Vol. 28 No. 3 - User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition 12. EP17-A2 Vol. 32 No. 8 - Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition 13. EP24-A2 Vol. 31 No. 23 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition 14. EP25-A Vol. 29 No. 20 - Evaluation of Stability of in Vitro Diagnostic Reagents; Approved Guideline 15. M29-A4 Vol. 34 No. 8 - Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline - 4th Edition 16. MM03 - Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline, 3rd Edition 5 17. MM06-A2 Vol. 30 No. 22 - Quantitative Molecular Methods for Infectious Diseases; Approved Guideline Second Edition 18. MM09-A2 Vol. 34 No.4 - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline 19. MM13-A Vol. 25 No. 31 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline 20. MM17 Ed 2 Vol. 38 No. 9 - Verification and Validation of Multiplex Nucleic Acid Assays (NATS); Approved Guideline L. Test Principle: The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are Regulation section:

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K180559.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

utaneous HSV 1&2 Expected Values by Lesion Source Lesion Source Total HSV 1&2 ELITe MGB Assay HSV-1 results HSV 1&2 ELITe MGB Assay HSV-2 results Positive Prevalence Positive Prevalence Genital/Vaginal/Cervical 501 109 21.8% 163 32.5% Oral 74 21 28.4% 2 2.7% Other 27 5 18.5% 2 7.4 % Anorectal 12 2 16.7% 5 41.7% Urethral 6 0 0 % 0 0 % Ocular 5 0 0 % 0 0 % Nasal 2 1 50.0 % 0 0 % Overall 627 138 22.0% 172 27.4% N. Instrument Name: ELITe InGenius system O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes _____X___ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X____ or No ________ 3. Specimen Identification: Not Applicable 4. Specimen Sampling and Handling: Not Applicable 23 5. Calibration: Not Applicable 6. Quality Control: Not Applicable P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagent and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process from 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction, and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The system can operate in three different modes: nucleic acid extraction only, PCR amplification only, or nucleic acid extraction with PCR amplification. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

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conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

ucocutaneous HSV 1&2 Expected Values by Lesion Source Lesion Source Total HSV 1&2 ELITe MGB Assay HSV-1 results HSV 1&2 ELITe MGB Assay HSV-2 results Positive Prevalence Positive Prevalence Genital/Vaginal/Cervical 501 109 21.8% 163 32.5% Oral 74 21 28.4% 2 2.7% Other 27 5 18.5% 2 7.4 % Anorectal 12 2 16.7% 5 41.7% Urethral 6 0 0 % 0 0 % Ocular 5 0 0 % 0 0 % Nasal 2 1 50.0 % 0 0 % Overall 627 138 22.0% 172 27.4% N. Instrument Name: ELITe InGenius system O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes _____X___ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___X_____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___X____ or No ________ 3. Specimen Identification: Not Applicable 4. Specimen Sampling and Handling: Not Applicable 23 5. Calibration: Not Applicable 6. Quality Control: Not Applicable P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: The HSV 1&2 ELITe MGB Assay is used on the ELITe InGenius system. The ELITe InGenius system is a bench top instrument integrating all required hardware, reagent and software components to perform nucleic acid sample preparation and real-time PCR operations. The ELITe InGenius system can process from 1 to 12 samples in 12 parallel tracks, and samples may be loaded in primary tubes or in secondary tubes provided. The system utilizes a universal, cassette-based process for sample extraction, and allows for multiple and independent PCRs to be performed from a single nucleic acid eluate. The system can operate in three different modes: nucleic acid extraction only, PCR amplification only, or nucleic acid extraction with PCR amplification. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK161220_s0_e2000

K161220.txt

purpose for submission

Clearance of New Device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161220 B. Purpose for Submission: Clearance of New Device C. Measurand: Influenza A RNA: Matrix gene Influenza B RNA: Matrix gene Respiratory Syncytial Virus (RSV) RNA: Fusion gene of RSV A and RSV B D. Type of Test: Qualitative Real Time Polymerase Chain Reaction (PCR) E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES® Flu A/B & RSV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OCC – Respiratory virus panel nucleic acid assay system 2 OOI – Real time nucleic acid amplification system OZE - influenza A and influenza B multiplex nucleic acid assay 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems. 2. Indication(s) for use: Same as intended use 3 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: For use with the ARIES System or ARIES M1 System Note: The ARIES System and ARIES M1 System are collectively referred to as the ARIES Systems throughout this memo. I. Device Description: The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES Systems with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control, and an assay-specific master mix designed to perform the designated assay on one sample. The ARIES Flu A/B & RSV Assay cassette is used to directly detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in NPS specimens from patients with signs and symptoms of respiratory tract infection. The assay detects the matrix protein genes of influenza A and influenza B viruses, the fusion gene of RSV, and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using the ARIES Systems. An extractable sample processing control (SPC) target is present in the ARIES Flu A/B & RSV assay cassette and is processed with the specimen. The Ct (threshold cycle) value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition if any, and verify proper function of the extraction system and the real-time PCR instrument. The Tm (melting temperature) value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contains target-specific primer pairs labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the ARIES Systems. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific Tm that is indicated by an increase in fluorescence. The instrument fluorescence output is analyzed and test results are determined using the ARIES Flu A/B & RSV Assay Protocol File. A printed results report is generated. Materials Provided · ARIES Flu A/B & RSV Assay Cassette Kit – contains 24 assay cassettes which contain necessary reagents for sample extraction, nucleic acid purification, and amplification. 4 · ARIES Flu A/B & RSV Assay Protocol File Kit – contains the assay protocol file, package insert, and ARIES Quick Guide provided on a USB drive. Materials Required But Not Provided Reagents for sample collection: · Nasopharyngeal swab (NPS) (flocked, polyester, or rayon swab) · Universal Transport Medium (UTM) Equipment: · -65°C to -95°C freezer · 2°C to 8°C refrigerator · Luminex ARIES Systems (either an ARIES System or an ARIES M1 System) and accessories Ø ARIES magazines Ø Sample Prep Tray · Vortex mixer · Appropriately sized pipettor Plasticware and Consumables: · Nuclease-free aerosol-barrier pipette tips J. Substantial Equivalence Information: 1. Predicate device name(s): Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack 2. Predicate 510(k) number(s): K120413 3. Comparison with predicate: Similarities Item Subject Device ARIES Flu A/B & RSV Assay (K161220) Predicate SimplexaTM Flu A/B & RSV Direct (K120413) Regulation 866.3980 866.3980 Product Code OCC, OOI, OZE OCC, OOI Device Classification II II Intended Use The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler 5 direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES Systems. instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (N Purpose for submission:

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K161220.txt

type of test

Qualitative Real Time Polymerase Chain Reaction (PCR)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161220 B. Purpose for Submission: Clearance of New Device C. Measurand: Influenza A RNA: Matrix gene Influenza B RNA: Matrix gene Respiratory Syncytial Virus (RSV) RNA: Fusion gene of RSV A and RSV B D. Type of Test: Qualitative Real Time Polymerase Chain Reaction (PCR) E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES® Flu A/B & RSV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OCC – Respiratory virus panel nucleic acid assay system 2 OOI – Real time nucleic acid amplification system OZE - influenza A and influenza B multiplex nucleic acid assay 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems. 2. Indication(s) for use: Same as intended use 3 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: For use with the ARIES System or ARIES M1 System Note: The ARIES System and ARIES M1 System are collectively referred to as the ARIES Systems throughout this memo. I. Device Description: The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES Systems with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control, and an assay-specific master mix designed to perform the designated assay on one sample. The ARIES Flu A/B & RSV Assay cassette is used to directly detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in NPS specimens from patients with signs and symptoms of respiratory tract infection. The assay detects the matrix protein genes of influenza A and influenza B viruses, the fusion gene of RSV, and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using the ARIES Systems. An extractable sample processing control (SPC) target is present in the ARIES Flu A/B & RSV assay cassette and is processed with the specimen. The Ct (threshold cycle) value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition if any, and verify proper function of the extraction system and the real-time PCR instrument. The Tm (melting temperature) value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contains target-specific primer pairs labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the ARIES Systems. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific Tm that is indicated by an increase in fluorescence. The instrument fluorescence output is analyzed and test results are determined using the ARIES Flu A/B & RSV Assay Protocol File. A printed results report is generated. Materials Provided · ARIES Flu A/B & RSV Assay Cassette Kit – contains 24 assay cassettes which contain necessary reagents for sample extraction, nucleic acid purification, and amplification. 4 · ARIES Flu A/B & RSV Assay Protocol File Kit – contains the assay protocol file, package insert, and ARIES Quick Guide provided on a USB drive. Materials Required But Not Provided Reagents for sample collection: · Nasopharyngeal swab (NPS) (flocked, polyester, or rayon swab) · Universal Transport Medium (UTM) Equipment: · -65°C to -95°C freezer · 2°C to 8°C refrigerator · Luminex ARIES Systems (either an ARIES System or an ARIES M1 System) and accessories Ø ARIES magazines Ø Sample Prep Tray · Vortex mixer · Appropriately sized pipettor Plasticware and Consumables: · Nuclease-free aerosol-barrier pipette tips J. Substantial Equivalence Information: 1. Predicate device name(s): Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack 2. Predicate 510(k) number(s): K120413 3. Comparison with predicate: Similarities Item Subject Device ARIES Flu A/B & RSV Assay (K161220) Predicate SimplexaTM Flu A/B & RSV Direct (K120413) Regulation 866.3980 866.3980 Product Code OCC, OOI, OZE OCC, OOI Device Classification II II Intended Use The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler 5 direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES Systems. instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (N Type of test:

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K161220.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161220 B. Purpose for Submission: Clearance of New Device C. Measurand: Influenza A RNA: Matrix gene Influenza B RNA: Matrix gene Respiratory Syncytial Virus (RSV) RNA: Fusion gene of RSV A and RSV B D. Type of Test: Qualitative Real Time Polymerase Chain Reaction (PCR) E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES® Flu A/B & RSV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OCC – Respiratory virus panel nucleic acid assay system 2 OOI – Real time nucleic acid amplification system OZE - influenza A and influenza B multiplex nucleic acid assay 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems. 2. Indication(s) for use: Same as intended use 3 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: For use with the ARIES System or ARIES M1 System Note: The ARIES System and ARIES M1 System are collectively referred to as the ARIES Systems throughout this memo. I. Device Description: The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES Systems with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control, and an assay-specific master mix designed to perform the designated assay on one sample. The ARIES Flu A/B & RSV Assay cassette is used to directly detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in NPS specimens from patients with signs and symptoms of respiratory tract infection. The assay detects the matrix protein genes of influenza A and influenza B viruses, the fusion gene of RSV, and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using the ARIES Systems. An extractable sample processing control (SPC) target is present in the ARIES Flu A/B & RSV assay cassette and is processed with the specimen. The Ct (threshold cycle) value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition if any, and verify proper function of the extraction system and the real-time PCR instrument. The Tm (melting temperature) value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contains target-specific primer pairs labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the ARIES Systems. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific Tm that is indicated by an increase in fluorescence. The instrument fluorescence output is analyzed and test results are determined using the ARIES Flu A/B & RSV Assay Protocol File. A printed results report is generated. Materials Provided · ARIES Flu A/B & RSV Assay Cassette Kit – contains 24 assay cassettes which contain necessary reagents for sample extraction, nucleic acid purification, and amplification. 4 · ARIES Flu A/B & RSV Assay Protocol File Kit – contains the assay protocol file, package insert, and ARIES Quick Guide provided on a USB drive. Materials Required But Not Provided Reagents for sample collection: · Nasopharyngeal swab (NPS) (flocked, polyester, or rayon swab) · Universal Transport Medium (UTM) Equipment: · -65°C to -95°C freezer · 2°C to 8°C refrigerator · Luminex ARIES Systems (either an ARIES System or an ARIES M1 System) and accessories Ø ARIES magazines Ø Sample Prep Tray · Vortex mixer · Appropriately sized pipettor Plasticware and Consumables: · Nuclease-free aerosol-barrier pipette tips J. Substantial Equivalence Information: 1. Predicate device name(s): Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack 2. Predicate 510(k) number(s): K120413 3. Comparison with predicate: Similarities Item Subject Device ARIES Flu A/B & RSV Assay (K161220) Predicate SimplexaTM Flu A/B & RSV Direct (K120413) Regulation 866.3980 866.3980 Product Code OCC, OOI, OZE OCC, OOI Device Classification II II Intended Use The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler 5 direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES Systems. instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (N Classification:

idK161220_s0_e2000

K161220.txt

panel

Microbiology (83)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161220 B. Purpose for Submission: Clearance of New Device C. Measurand: Influenza A RNA: Matrix gene Influenza B RNA: Matrix gene Respiratory Syncytial Virus (RSV) RNA: Fusion gene of RSV A and RSV B D. Type of Test: Qualitative Real Time Polymerase Chain Reaction (PCR) E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES® Flu A/B & RSV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OCC – Respiratory virus panel nucleic acid assay system 2 OOI – Real time nucleic acid amplification system OZE - influenza A and influenza B multiplex nucleic acid assay 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems. 2. Indication(s) for use: Same as intended use 3 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: For use with the ARIES System or ARIES M1 System Note: The ARIES System and ARIES M1 System are collectively referred to as the ARIES Systems throughout this memo. I. Device Description: The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES Systems with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control, and an assay-specific master mix designed to perform the designated assay on one sample. The ARIES Flu A/B & RSV Assay cassette is used to directly detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in NPS specimens from patients with signs and symptoms of respiratory tract infection. The assay detects the matrix protein genes of influenza A and influenza B viruses, the fusion gene of RSV, and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using the ARIES Systems. An extractable sample processing control (SPC) target is present in the ARIES Flu A/B & RSV assay cassette and is processed with the specimen. The Ct (threshold cycle) value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition if any, and verify proper function of the extraction system and the real-time PCR instrument. The Tm (melting temperature) value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contains target-specific primer pairs labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the ARIES Systems. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific Tm that is indicated by an increase in fluorescence. The instrument fluorescence output is analyzed and test results are determined using the ARIES Flu A/B & RSV Assay Protocol File. A printed results report is generated. Materials Provided · ARIES Flu A/B & RSV Assay Cassette Kit – contains 24 assay cassettes which contain necessary reagents for sample extraction, nucleic acid purification, and amplification. 4 · ARIES Flu A/B & RSV Assay Protocol File Kit – contains the assay protocol file, package insert, and ARIES Quick Guide provided on a USB drive. Materials Required But Not Provided Reagents for sample collection: · Nasopharyngeal swab (NPS) (flocked, polyester, or rayon swab) · Universal Transport Medium (UTM) Equipment: · -65°C to -95°C freezer · 2°C to 8°C refrigerator · Luminex ARIES Systems (either an ARIES System or an ARIES M1 System) and accessories Ø ARIES magazines Ø Sample Prep Tray · Vortex mixer · Appropriately sized pipettor Plasticware and Consumables: · Nuclease-free aerosol-barrier pipette tips J. Substantial Equivalence Information: 1. Predicate device name(s): Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack 2. Predicate 510(k) number(s): K120413 3. Comparison with predicate: Similarities Item Subject Device ARIES Flu A/B & RSV Assay (K161220) Predicate SimplexaTM Flu A/B & RSV Direct (K120413) Regulation 866.3980 866.3980 Product Code OCC, OOI, OZE OCC, OOI Device Classification II II Intended Use The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler 5 direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES Systems. instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (N Panel:

idK161220_s0_e2000

K161220.txt

applicant

Luminex Corporation

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161220 B. Purpose for Submission: Clearance of New Device C. Measurand: Influenza A RNA: Matrix gene Influenza B RNA: Matrix gene Respiratory Syncytial Virus (RSV) RNA: Fusion gene of RSV A and RSV B D. Type of Test: Qualitative Real Time Polymerase Chain Reaction (PCR) E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES® Flu A/B & RSV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OCC – Respiratory virus panel nucleic acid assay system 2 OOI – Real time nucleic acid amplification system OZE - influenza A and influenza B multiplex nucleic acid assay 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems. 2. Indication(s) for use: Same as intended use 3 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: For use with the ARIES System or ARIES M1 System Note: The ARIES System and ARIES M1 System are collectively referred to as the ARIES Systems throughout this memo. I. Device Description: The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES Systems with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control, and an assay-specific master mix designed to perform the designated assay on one sample. The ARIES Flu A/B & RSV Assay cassette is used to directly detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in NPS specimens from patients with signs and symptoms of respiratory tract infection. The assay detects the matrix protein genes of influenza A and influenza B viruses, the fusion gene of RSV, and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using the ARIES Systems. An extractable sample processing control (SPC) target is present in the ARIES Flu A/B & RSV assay cassette and is processed with the specimen. The Ct (threshold cycle) value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition if any, and verify proper function of the extraction system and the real-time PCR instrument. The Tm (melting temperature) value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contains target-specific primer pairs labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the ARIES Systems. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific Tm that is indicated by an increase in fluorescence. The instrument fluorescence output is analyzed and test results are determined using the ARIES Flu A/B & RSV Assay Protocol File. A printed results report is generated. Materials Provided · ARIES Flu A/B & RSV Assay Cassette Kit – contains 24 assay cassettes which contain necessary reagents for sample extraction, nucleic acid purification, and amplification. 4 · ARIES Flu A/B & RSV Assay Protocol File Kit – contains the assay protocol file, package insert, and ARIES Quick Guide provided on a USB drive. Materials Required But Not Provided Reagents for sample collection: · Nasopharyngeal swab (NPS) (flocked, polyester, or rayon swab) · Universal Transport Medium (UTM) Equipment: · -65°C to -95°C freezer · 2°C to 8°C refrigerator · Luminex ARIES Systems (either an ARIES System or an ARIES M1 System) and accessories Ø ARIES magazines Ø Sample Prep Tray · Vortex mixer · Appropriately sized pipettor Plasticware and Consumables: · Nuclease-free aerosol-barrier pipette tips J. Substantial Equivalence Information: 1. Predicate device name(s): Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack 2. Predicate 510(k) number(s): K120413 3. Comparison with predicate: Similarities Item Subject Device ARIES Flu A/B & RSV Assay (K161220) Predicate SimplexaTM Flu A/B & RSV Direct (K120413) Regulation 866.3980 866.3980 Product Code OCC, OOI, OZE OCC, OOI Device Classification II II Intended Use The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler 5 direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES Systems. instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (N Applicant:

idK161220_s0_e2000

K161220.txt

proprietary and established names

ARIES® Flu A/B & RSV Assay

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161220 B. Purpose for Submission: Clearance of New Device C. Measurand: Influenza A RNA: Matrix gene Influenza B RNA: Matrix gene Respiratory Syncytial Virus (RSV) RNA: Fusion gene of RSV A and RSV B D. Type of Test: Qualitative Real Time Polymerase Chain Reaction (PCR) E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES® Flu A/B & RSV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OCC – Respiratory virus panel nucleic acid assay system 2 OOI – Real time nucleic acid amplification system OZE - influenza A and influenza B multiplex nucleic acid assay 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems. 2. Indication(s) for use: Same as intended use 3 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: For use with the ARIES System or ARIES M1 System Note: The ARIES System and ARIES M1 System are collectively referred to as the ARIES Systems throughout this memo. I. Device Description: The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES Systems with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control, and an assay-specific master mix designed to perform the designated assay on one sample. The ARIES Flu A/B & RSV Assay cassette is used to directly detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in NPS specimens from patients with signs and symptoms of respiratory tract infection. The assay detects the matrix protein genes of influenza A and influenza B viruses, the fusion gene of RSV, and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using the ARIES Systems. An extractable sample processing control (SPC) target is present in the ARIES Flu A/B & RSV assay cassette and is processed with the specimen. The Ct (threshold cycle) value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition if any, and verify proper function of the extraction system and the real-time PCR instrument. The Tm (melting temperature) value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contains target-specific primer pairs labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the ARIES Systems. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific Tm that is indicated by an increase in fluorescence. The instrument fluorescence output is analyzed and test results are determined using the ARIES Flu A/B & RSV Assay Protocol File. A printed results report is generated. Materials Provided · ARIES Flu A/B & RSV Assay Cassette Kit – contains 24 assay cassettes which contain necessary reagents for sample extraction, nucleic acid purification, and amplification. 4 · ARIES Flu A/B & RSV Assay Protocol File Kit – contains the assay protocol file, package insert, and ARIES Quick Guide provided on a USB drive. Materials Required But Not Provided Reagents for sample collection: · Nasopharyngeal swab (NPS) (flocked, polyester, or rayon swab) · Universal Transport Medium (UTM) Equipment: · -65°C to -95°C freezer · 2°C to 8°C refrigerator · Luminex ARIES Systems (either an ARIES System or an ARIES M1 System) and accessories Ø ARIES magazines Ø Sample Prep Tray · Vortex mixer · Appropriately sized pipettor Plasticware and Consumables: · Nuclease-free aerosol-barrier pipette tips J. Substantial Equivalence Information: 1. Predicate device name(s): Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack 2. Predicate 510(k) number(s): K120413 3. Comparison with predicate: Similarities Item Subject Device ARIES Flu A/B & RSV Assay (K161220) Predicate SimplexaTM Flu A/B & RSV Direct (K120413) Regulation 866.3980 866.3980 Product Code OCC, OOI, OZE OCC, OOI Device Classification II II Intended Use The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler 5 direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES Systems. instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (N Proprietary and established names:

idK161220_s0_e2000

K161220.txt

regulation section

21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161220 B. Purpose for Submission: Clearance of New Device C. Measurand: Influenza A RNA: Matrix gene Influenza B RNA: Matrix gene Respiratory Syncytial Virus (RSV) RNA: Fusion gene of RSV A and RSV B D. Type of Test: Qualitative Real Time Polymerase Chain Reaction (PCR) E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES® Flu A/B & RSV Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OCC – Respiratory virus panel nucleic acid assay system 2 OOI – Real time nucleic acid amplification system OZE - influenza A and influenza B multiplex nucleic acid assay 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES® Systems. 2. Indication(s) for use: Same as intended use 3 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: For use with the ARIES System or ARIES M1 System Note: The ARIES System and ARIES M1 System are collectively referred to as the ARIES Systems throughout this memo. I. Device Description: The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES Systems with its included software, an assay-specific cassette, and an assay-specific protocol file. The ARIES Flu A/B & RSV Assay cassette is a disposable, single-use cassette containing nucleic acid purification reagents, internal sample process control, and an assay-specific master mix designed to perform the designated assay on one sample. The ARIES Flu A/B & RSV Assay cassette is used to directly detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in NPS specimens from patients with signs and symptoms of respiratory tract infection. The assay detects the matrix protein genes of influenza A and influenza B viruses, the fusion gene of RSV, and a RNA Sample Processing Control. The specimen is lysed and nucleic acid is extracted using the ARIES Systems. An extractable sample processing control (SPC) target is present in the ARIES Flu A/B & RSV assay cassette and is processed with the specimen. The Ct (threshold cycle) value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition if any, and verify proper function of the extraction system and the real-time PCR instrument. The Tm (melting temperature) value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid and SPC are transferred via magnetic beads through the cassette to the ARIES Flu A/B & RSV Assay lyophilized PCR reagents in the PCR tube that contains target-specific primer pairs labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the ARIES Systems. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific Tm that is indicated by an increase in fluorescence. The instrument fluorescence output is analyzed and test results are determined using the ARIES Flu A/B & RSV Assay Protocol File. A printed results report is generated. Materials Provided · ARIES Flu A/B & RSV Assay Cassette Kit – contains 24 assay cassettes which contain necessary reagents for sample extraction, nucleic acid purification, and amplification. 4 · ARIES Flu A/B & RSV Assay Protocol File Kit – contains the assay protocol file, package insert, and ARIES Quick Guide provided on a USB drive. Materials Required But Not Provided Reagents for sample collection: · Nasopharyngeal swab (NPS) (flocked, polyester, or rayon swab) · Universal Transport Medium (UTM) Equipment: · -65°C to -95°C freezer · 2°C to 8°C refrigerator · Luminex ARIES Systems (either an ARIES System or an ARIES M1 System) and accessories Ø ARIES magazines Ø Sample Prep Tray · Vortex mixer · Appropriately sized pipettor Plasticware and Consumables: · Nuclease-free aerosol-barrier pipette tips J. Substantial Equivalence Information: 1. Predicate device name(s): Simplexa™ Flu A/B & RSV Direct Simplexa™ Flu A/B & RSV Positive Control Pack 2. Predicate 510(k) number(s): K120413 3. Comparison with predicate: Similarities Item Subject Device ARIES Flu A/B & RSV Assay (K161220) Predicate SimplexaTM Flu A/B & RSV Direct (K120413) Regulation 866.3980 866.3980 Product Code OCC, OOI, OZE OCC, OOI Device Classification II II Intended Use The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler 5 direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swab (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial culture, immunofluorescence, X-ray findings) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for influenza A were established during the 2014-2015 and the 2015-2016 influenza seasons when influenza A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The ARIES® Flu A/B & RSV Assay is indicated for use with the ARIES Systems. instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (N Regulation section:

idK161220_s16000_e18000

K161220.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

13.7% 79 19.8% N. Instrument Name: ARIES System and ARIES M1 System O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___x_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___x_____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___x_____ or No ________ 3. Specimen Identification: A barcode reader may be used for entry of sample IDs, or they may be entered manually. 4. Specimen Sampling and Handling: NPS specimens are manually prepared following the user institution’s standard procedures and are transferred to an ARIES Flu A/B & RSV assay cassette for analysis. 30 5. Calibration: Calibration is performed by Luminex service personnel using ARIES System Verification Cassettes. 6. Quality Control: Each ARIES Flu A/B & RSV assay cassette includes a SPC. The SPC has a known melting temperature (Tm) range and cycle threshold (Ct) range. Each time an assay is run, the system measures the temperature and fluorescence intensity of the SPC control to ensure the thermal and optical subsystems have remained in calibration. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not Applicable. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK161220_s16000_e18000

K161220.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

% 53 13.7% 79 19.8% N. Instrument Name: ARIES System and ARIES M1 System O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___x_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___x_____ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ___x_____ or No ________ 3. Specimen Identification: A barcode reader may be used for entry of sample IDs, or they may be entered manually. 4. Specimen Sampling and Handling: NPS specimens are manually prepared following the user institution’s standard procedures and are transferred to an ARIES Flu A/B & RSV assay cassette for analysis. 30 5. Calibration: Calibration is performed by Luminex service personnel using ARIES System Verification Cassettes. 6. Quality Control: Each ARIES Flu A/B & RSV assay cassette includes a SPC. The SPC has a known melting temperature (Tm) range and cycle threshold (Ct) range. Each time an assay is run, the system measures the temperature and fluorescence intensity of the SPC control to ensure the thermal and optical subsystems have remained in calibration. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Not Applicable. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK150588_s0_e2000

K150588.txt

purpose for submission

New device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Purpose for submission:

idK150588_s0_e2000

K150588.txt

measurand

Score based on 5 serum analytes

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Measurand:

idK150588_s0_e2000

K150588.txt

type of test

Software algorithm that combines five immunoassays into a single score

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Type of test:

idK150588_s0_e2000

K150588.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Classification:

idK150588_s0_e2000

K150588.txt

product code

ONX, Serum, algorithm, ovarian cancer assessment test

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Product code:

idK150588_s0_e2000

K150588.txt

panel

Immunology (82)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Panel:

idK150588_s0_e2000

K150588.txt

predicate device name

Vermillion OVA1

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Predicate device name:

idK150588_s0_e2000

K150588.txt

applicant

Vermillion, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Applicant:

idK150588_s0_e2000

K150588.txt

proprietary and established names

OVA1 Next Generation

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Proprietary and established names:

idK150588_s0_e2000

K150588.txt

regulation section

21 CFR §866.6050, Ovarian adnexal mass assessment score test system

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K150588 B. Purpose for Submission: New device C. Measurand: Score based on 5 serum analytes D. Type of Test: Software algorithm that combines five immunoassays into a single score E. Applicant: Vermillion, Inc. F. Proprietary and Established Names: OVA1 Next Generation G. Regulatory Information: 1. Regulation section: 21 CFR §866.6050, Ovarian adnexal mass assessment score test system 2. Classification: Class II 3. Product code: ONX, Serum, algorithm, ovarian cancer assessment test 4. Panel: Immunology (82) 2 H. Intended Use: 1. Intended use(s): The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. 2. Indication(s) for use: Same as Intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: For use on Roche cobas® 6000 system I. Device Description: The OVA1 Next Generation test consists of software, instruments, assays and reagents. The software incorporates the results of five serum biomarker concentrations from immunoassays run separately to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The biomarkers and corresponding immunoassays and calibrators used to generate the numeric result (OVA1 Next Generation score) are: Analyte Reagent and Calibrator Instrument Apolipoprotein A-1 (APO) cobas APO A1 C.f.a.s. Lipids Roche cobas® 6000: Roche cobas® c501 CA 125 II cobas CA 125 II CA 125 II Cal Set Roche cobas® 6000: Roche cobas® e601 Follicle Stimulating Hormone (FSH) cobas FSH FSH Cal Set II Roche cobas® 6000: Roche cobas® e601 Human epididymis protein 4 (HE4) cobas HE4 HE4 Cal Set Roche cobas® 6000: Roche cobas® e601 3 Analyte Reagent and Calibrator Instrument Transferrin (TRF) cobas Transferrin C.f.a.s. Proteins Roche cobas® 6000: Roche cobas® c501 The biomarker immunoassays and reagents are sold separately from the OVA1 Next Generation software (OvaCalc). All immunoassays are run on the Roche cobas® 6000 system according to the manufacturer’s instructions as detailed in the product insert for each reagent. Users are instructed to use only qualified lot numbers for the immunoassays as posted on www.vermillion.com. Roche cobas® 6000 system is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The OvaCalc software (v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker immunoassays. The assay values from the cobas® 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 Next Generation score between 0.0 and 10.0. OVA1 Next Generation score: Low probability of malignancy Risk score < 5.0 High probability of malignancy Risk score ≥ 5.0 J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): Vermillion OVA1, K081754 2. Comparison with predicate: Similarities Item New Device OVA1 Next Generation Predicate OVA1 Test Intended Use/ Indication for Use The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. Boxed Warning Should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use carries the risk of unnecessary testing, surgery, and / or delayed diagnosis. Same The test is not intended as a screening or stand-alone diagnostic assay. Sample Matrix Serum Same Type of Test Algorithm Same 4 Differences Item New Device OVA1 Next Generation Predicate OVA1 Test Analytes Roche Elecsys APO, CA 125, TRF, FSH, HE4 Roche Elecsys CA 125 and Siemens BN II APO, TRF, Prealbumin, β2 Microglobulin Equation used for test One equation with one cut-off One equation with two cut-offs depending on menopausal status Clinical cutoff Pre-menopausal and Post-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Pre-menopausal: • OVA1 risk score < 5.0 Low probability for malignancy • OVA1 risk score ≥ 5.0 High probability for malignancy Post-menopausal: • OVA1 risk score < 4.4 Low probability for malignancy • OVA1 risk score ≥ 4.4 High probability for malignancy Platform Roche cobas e601 (CA125, FSH and HE4) Roche cobas c501 (APO and TRF) Roche Elecsys 2010 (CA 125) Siemens BNII (APO, TRF, Prealbumin, β2 Microglobulin) K. Standard/Guidance Document Referenced (if applicable): 5 • FDA Guidance “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” • FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” • ISO 14971:2012 Medical Devices-Application of Risk Management to Medical Devices, International Organization for Standardization. • CLSI guideline EP05-A2, “Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.” • CLSI guideline EP07-A2, “Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition.” L. Test Principle: The individual assays for APO and TRF each contain a biomarker specific polyclonal antibody which forms an immune complex with the target when reacted with a serum specimen. The levels of immune complexes can be measured turbidimetrically and are proportional to the concentration of biomarker in the serum specimen for each specific assay. The individual assays for CA 125 II, FSH and HE4 each use two mouse monoclonal antibodies to their respective biomarkers. The quantity of each biomarker present is then measured by chemiluminescence emission. The Cobas 6000 is an automated analyzer with electrochemiluminescence detection. The amount of analyte in each assay is determined against the calibration curve. Each assay uses its own specific calibrator and controls. The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these five analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0. M. Performance Characteristics (if/when applicable): 1. Analytical performance: All results met the manufacturer’s pre-determined acceptance criteria. a. Precision: Precision performance of the OVA1 Next Generation test was evaluated in accordance with CLSI guideline EP05-A2 “Eval Regulation section:

idK150588_s12000_e14000

K150588.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

a stand-alone diagnostic test. * - Performance was considered statistically different if the 95% CI of the difference did not bound or contain zero. Stage N OVA1 Next Generation Sensitivity% OVA1 Test Sensitivity% I 10 90.0% (9/10) 90.0% (9/10) II 1 100% (1/1) 100% (1/1) III 9 88.9% (8/9) 88.9% (8/9) IV 3 66.7% (2/3) 100% (3/3) Not Staged 5 40.0% (2/5) 40.0% (2/5) a- Characterization evaluated stand-alone risk stratification versus cutoff, without regard to results of physician assessment. OVA1 Next Generation is not intended as a stand-alone diagnostic test. 23 5. Expected values/Reference range: The reference interval of OVA1 Next Generation test was determined in 68 pre-menopausal and 84 post-menopausal healthy women (total = 152 evaluable subjects). Ages ranged from 18 to 91 years and represented whites (84.9%), Hispanic/Latino (7.2%) and African American (5.3%) subjects. The mean, SD, median, range and 5th to 95th percentile of OVA1 Next Generation scores and the OVA1 Next Generation test results are shown for each group in the table below. It is recommended that each laboratory establish its own reference range for the population of interest. Expected Values in Non-Ovarian Malignancy Condition: To evaluate the performance of the OVA1 Next Generation test in subjects with other disease conditions, patients with cancer conditions other than ovarian cancer (bladder cancer, breast cancer, cervical cancer, colon cancer, endometrial cancer, lung cancer, leukemia and lymphoma) and patients with non-cancer conditions (autoimmune disease, cardiac disease, diabetes, endometriosis, hepatitis and kidney diseases) were evaluated. Evaluable Specimens from Subjects with non- Ovarian Cancers and Other Conditions Bladder cancer 20 Breast cancer 40 Cervical cancer 20 Colon cancer 40 Endometrial cancer 40 Leukemia 11 Lung cancer 40 Lymphoma 10 Autoimmune disease 20 Cardiac disease 20 OVA1 Next Generation Scores and Results in Healthy Subjects All Evaluable Subjects Pre- menopausal Women Post- menopausal Women n (%) 152 (100) 68 (44.7) 84 (55.3) Mean age (SD) 51.0 (13.75) 39.2 (8.23) 60.5 (9.22) Median age 51 41 59 OVA1 Next Generation score Mean (SD) 3.94 (0.984) 3.72 (0.938) 4.12 (0.989) Median 3.90 3.60 4.05 Range (min, max) (2.2, 7.1) (2.2, 6.1) (2.5, 7.1) Reference interval (5th, 95th percentiles) (2.5, 5.9) (2.4, 5.3) (2.9, 5.9) OVA1 Next Generation result, n (%) Positive 23 (15.1%) 9 (13.2% ) 14 (16.7%) Negative 129 (84.9%) 59 (86.8% ) 70 (83.3%) 24 Evaluable Specimens from Subjects with non- Ovarian Cancers and Other Conditions Diabetes 40 Endometriosis 40 Hepatitis 20 Kidney disease 20 Pregnant women 20 All specimens 401 The mean, median, standard deviation, 5th to 95th percentiles as observed in the data are shown for each condition group. Using the defined cut-off of 5.0 for OVA1 Next Generation scores, the number of positive (≥ 5.0) and negative (< 5.0) cases is presented below: OVA1 Next Generation Scores and Results in Subjects with Non-Ovarian Cancers Bladder Cancer Breast Cancer Cervical Cancer Colon Cancer Endometrial Cancer Leukemia Lung Cancer Lymphoma n 20 40 20 40 40 11 40 10 OVA1 Next Generation score, statistics Mean (SD) 5.32 (1.83) 4.03 (1.22) 6.56 (1.91) 5.11 (1.73) 5.45 (1.72) 6.66 (1.30) 5.02 (1.38) 6.10 (1.91) Median 4.8 3.9 7.7 4.6 4.8 7.2 4.9 6.0 5th, 95th percentiles 2.9, 8.2 2.8, 6.6 3.5, 8.5 3.0, 7.7 3.1, 8.1 4.4, 8.1 3.1, 7.5 2.4, 8.5 Range min, max 2.8, 8.5 2.6, 8.4 2.6, 8.5 2.4, 8.1 3.0,8.1 4.4, 8.1 2.8, 7.8 2.4, 8.5 OVA1 Next Generation test result, n Positive 10 6 13 18 20 10 18 8 Negative 10 34 7 22 20 1 22 2 % negative results 50 85 35 55 50 9.1 55 20 OVA1 Next Generation Scores and Results in Subjects with Conditions Other than Cancers Autoimmune Disease Cardiac Disease Diabetes Endometriosis Hepatitis Kidney Disease Pregnant Women n 20 20 40 40 20 20 20 OVA1 Next Generation score, statistics Mean (SD) 5.52 (1.86) 6.12 (1.58) 4.72 (1.67) 4.35 (1.38) 5.19 (1.78) 6.65 (1.37) 5.31 (0.35) Median 5.9 6.4 4.2 4.2 5.1 7.2 5.3 5th, 95th percentiles 2.8, 8.2 3.6, 8.1 2.5, 8.1 2.5, 7.2 3.0, 7.9 3.8, 8.3 4.8, 6.0 Range min, max 2.4, 8.3 3.3, 8.3 2.0, 8.1 2.2, 7.9 2.7, 7.9 3.3, 8.3 4.5, 6.2 25 OVA1 Next Generation test result, n Positive 11 15 14 11 11 18 19 Negative 9 5 26 29 9 2 1 % negative results 45 25 65 72.5 45 10 5 The number of cases is small within each of the examined diseases and conditions, but the results suggest that caution is warranted when interpreting OVA1 Next Generation results for pregnant women and patients with cervical cancer, leukemia, lymphoma, cardiac disease, kidney disease. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK150588_s12000_e14000

K150588.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

intended as a stand-alone diagnostic test. * - Performance was considered statistically different if the 95% CI of the difference did not bound or contain zero. Stage N OVA1 Next Generation Sensitivity% OVA1 Test Sensitivity% I 10 90.0% (9/10) 90.0% (9/10) II 1 100% (1/1) 100% (1/1) III 9 88.9% (8/9) 88.9% (8/9) IV 3 66.7% (2/3) 100% (3/3) Not Staged 5 40.0% (2/5) 40.0% (2/5) a- Characterization evaluated stand-alone risk stratification versus cutoff, without regard to results of physician assessment. OVA1 Next Generation is not intended as a stand-alone diagnostic test. 23 5. Expected values/Reference range: The reference interval of OVA1 Next Generation test was determined in 68 pre-menopausal and 84 post-menopausal healthy women (total = 152 evaluable subjects). Ages ranged from 18 to 91 years and represented whites (84.9%), Hispanic/Latino (7.2%) and African American (5.3%) subjects. The mean, SD, median, range and 5th to 95th percentile of OVA1 Next Generation scores and the OVA1 Next Generation test results are shown for each group in the table below. It is recommended that each laboratory establish its own reference range for the population of interest. Expected Values in Non-Ovarian Malignancy Condition: To evaluate the performance of the OVA1 Next Generation test in subjects with other disease conditions, patients with cancer conditions other than ovarian cancer (bladder cancer, breast cancer, cervical cancer, colon cancer, endometrial cancer, lung cancer, leukemia and lymphoma) and patients with non-cancer conditions (autoimmune disease, cardiac disease, diabetes, endometriosis, hepatitis and kidney diseases) were evaluated. Evaluable Specimens from Subjects with non- Ovarian Cancers and Other Conditions Bladder cancer 20 Breast cancer 40 Cervical cancer 20 Colon cancer 40 Endometrial cancer 40 Leukemia 11 Lung cancer 40 Lymphoma 10 Autoimmune disease 20 Cardiac disease 20 OVA1 Next Generation Scores and Results in Healthy Subjects All Evaluable Subjects Pre- menopausal Women Post- menopausal Women n (%) 152 (100) 68 (44.7) 84 (55.3) Mean age (SD) 51.0 (13.75) 39.2 (8.23) 60.5 (9.22) Median age 51 41 59 OVA1 Next Generation score Mean (SD) 3.94 (0.984) 3.72 (0.938) 4.12 (0.989) Median 3.90 3.60 4.05 Range (min, max) (2.2, 7.1) (2.2, 6.1) (2.5, 7.1) Reference interval (5th, 95th percentiles) (2.5, 5.9) (2.4, 5.3) (2.9, 5.9) OVA1 Next Generation result, n (%) Positive 23 (15.1%) 9 (13.2% ) 14 (16.7%) Negative 129 (84.9%) 59 (86.8% ) 70 (83.3%) 24 Evaluable Specimens from Subjects with non- Ovarian Cancers and Other Conditions Diabetes 40 Endometriosis 40 Hepatitis 20 Kidney disease 20 Pregnant women 20 All specimens 401 The mean, median, standard deviation, 5th to 95th percentiles as observed in the data are shown for each condition group. Using the defined cut-off of 5.0 for OVA1 Next Generation scores, the number of positive (≥ 5.0) and negative (< 5.0) cases is presented below: OVA1 Next Generation Scores and Results in Subjects with Non-Ovarian Cancers Bladder Cancer Breast Cancer Cervical Cancer Colon Cancer Endometrial Cancer Leukemia Lung Cancer Lymphoma n 20 40 20 40 40 11 40 10 OVA1 Next Generation score, statistics Mean (SD) 5.32 (1.83) 4.03 (1.22) 6.56 (1.91) 5.11 (1.73) 5.45 (1.72) 6.66 (1.30) 5.02 (1.38) 6.10 (1.91) Median 4.8 3.9 7.7 4.6 4.8 7.2 4.9 6.0 5th, 95th percentiles 2.9, 8.2 2.8, 6.6 3.5, 8.5 3.0, 7.7 3.1, 8.1 4.4, 8.1 3.1, 7.5 2.4, 8.5 Range min, max 2.8, 8.5 2.6, 8.4 2.6, 8.5 2.4, 8.1 3.0,8.1 4.4, 8.1 2.8, 7.8 2.4, 8.5 OVA1 Next Generation test result, n Positive 10 6 13 18 20 10 18 8 Negative 10 34 7 22 20 1 22 2 % negative results 50 85 35 55 50 9.1 55 20 OVA1 Next Generation Scores and Results in Subjects with Conditions Other than Cancers Autoimmune Disease Cardiac Disease Diabetes Endometriosis Hepatitis Kidney Disease Pregnant Women n 20 20 40 40 20 20 20 OVA1 Next Generation score, statistics Mean (SD) 5.52 (1.86) 6.12 (1.58) 4.72 (1.67) 4.35 (1.38) 5.19 (1.78) 6.65 (1.37) 5.31 (0.35) Median 5.9 6.4 4.2 4.2 5.1 7.2 5.3 5th, 95th percentiles 2.8, 8.2 3.6, 8.1 2.5, 8.1 2.5, 7.2 3.0, 7.9 3.8, 8.3 4.8, 6.0 Range min, max 2.4, 8.3 3.3, 8.3 2.0, 8.1 2.2, 7.9 2.7, 7.9 3.3, 8.3 4.5, 6.2 25 OVA1 Next Generation test result, n Positive 11 15 14 11 11 18 19 Negative 9 5 26 29 9 2 1 % negative results 45 25 65 72.5 45 10 5 The number of cases is small within each of the examined diseases and conditions, but the results suggest that caution is warranted when interpreting OVA1 Next Generation results for pregnant women and patients with cervical cancer, leukemia, lymphoma, cardiac disease, kidney disease. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK150815_s0_e2000

K150815.txt

purpose for submission

New assay and instrument

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150815 B. Purpose for Submission: New assay and instrument C. Measurand: Lymphocyte CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin concentration D. Type of Test: Quantitative test for CD4% and CD4 absolute count by cytometry imaging and quantitative test for hemoglobin by absorbance spectrometer E. Applicant: BD Biosciences F. Proprietary and Established Names: BD FACSPresto™ System BD FACSPresto™ CD4/Hb Cartridge BD FACSPresto™ CD4/Hb Cartridge Kit BD Multi-Check Control BD Multi-Check CD4 Low Control Eurotrol FACSPresto Hb Control (Levels 1−3) G. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 21 CFR §864.8625, Hematology Quality Control Mixture 2. Classification: 2 Class II (assay) Class II (controls) 3. Product code: PMG, Automated multicolor fluorescent imaging cytometric analysis system OYE, System, Test, Flow cytometric reagents and accessories GKL Hemoglobin assay JPK, Analyte Controls, Hematology Quality Control 4. Panel: Hematology (81) Immunology (82) H. Intended Use: 1. Intended use(s): Instrument BD FACSPresto™ System BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. • For use with the BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 of lymphocyte, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. Device BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. 3 • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. BD Multi-Check Control The BD Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. BD Multi-Check CD4 Low Control The BD Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto system, an imaging cytometer. Eurotrol FACSPresto Hb Control Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the FACSPresto System. 2. Indication(s) for use: Same as above 3. Special conditions for use statement(s): For Prescription Use Only 4. Special instrument requirements: BD FACSPresto™ System instrument I. Device Description: The device consists of the BD FACSPresto system, the BD FACSPresto CD4/Hb Cartridge, and the BD FACSPresto CD4/Hb Cartridge Kit. 4 BD FACSPresto System This instrument is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer with integrated BD FACSPresto System Software. BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Cartridge contains antibody-fluorochrome conjugates, CD4 PE- Cy5, CD3 APC, CD45RA-APC, and CD 14-PE, dried on a reagent disc and is embedded with reagent quality controls. Transfer Pipettes BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Finger Stick Sample Collection Kit (including lancets, alcohol pads, sponges, and bandages) The BD FACSPresto System (instrument) includes a power supply, adapter cords, instrument cover, a sample incubation work station, printer paper and a USB flash drive. BD Multi-Check Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium BD Multi-Check CD4 Low Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium Eurotrol FACSPresto Hb Control Levels 1−3 Process control composed of purified bovine hemolysate J. Substantial Equivalence Information: 1. Predicate device name(s): a. BD FACSCalibur using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes b. Sysmex Automated Hematology Analyzer KX-21N c. R&D Systems Whole Blood Flow Control, also known as StatusFlow d. StatusFlow Lo e. Eurotrol Hb 301 Control (Levels 1−3) 2. Predicate 510(k) number(s): a. K071141 b. K981761 c. K961610, BK990005 d. K982231 e. BK030067 3. Comparison with predicate: 5 Instrument Similarities and Differences Item Device BD FACSPresto System Predicate BD FACSCalibur Intended Use BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and /or measurement of absorbance spectrums. For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510−545 nm, 562−607 nm, and >650 nm • For use in erythrocyte-lysed whole peripheral blood • For use with or without isotype control • To characterize and monitor some forms of autoimmune disease • To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals Instrument Setup and Quality Control Setup: Automated instrument setup. Instrument QC: automated verification of instrument performance at power- on-self-test (POST) and during cartridge runs. Cartridge QC: rat anti-mouse antibodies bound to polystyrene beads confirm presence of sample and reagent. Setup: Semi-automated setup using BD FACSComp software with BD Calibrite beads for setting PMT voltages, fluorescence compensation, and checking instrument sensitivity. Software Integrated BD FACSPresto System Software Integrated software on instrument and BD MultiSet Software on external computer Optics Fluorescence excitation of stained cells in microfluidic channel by LED illumination; Fluorescence emission measured by CCD camera imaging Fluorescence excitation of stained cells in flow stream by laser illumination; Fluorescence emission measured by PMTs Cytometry Imaging Flow 6 Absolute CD4 Count and %CD4 Assays Similarities Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Results Reporting • Absolute CD4 count (cells/µL) • %CD4 (the percentage of CD4 positive lymphocytes counted within the total lymphocyte population count) Same Sample Type Whole blood Same Differences Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Intended Use/ Indications for Use BD FACSPrest Purpose for submission:

idK150815_s0_e2000

K150815.txt

measurand

Lymphocyte CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin concentration

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150815 B. Purpose for Submission: New assay and instrument C. Measurand: Lymphocyte CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin concentration D. Type of Test: Quantitative test for CD4% and CD4 absolute count by cytometry imaging and quantitative test for hemoglobin by absorbance spectrometer E. Applicant: BD Biosciences F. Proprietary and Established Names: BD FACSPresto™ System BD FACSPresto™ CD4/Hb Cartridge BD FACSPresto™ CD4/Hb Cartridge Kit BD Multi-Check Control BD Multi-Check CD4 Low Control Eurotrol FACSPresto Hb Control (Levels 1−3) G. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 21 CFR §864.8625, Hematology Quality Control Mixture 2. Classification: 2 Class II (assay) Class II (controls) 3. Product code: PMG, Automated multicolor fluorescent imaging cytometric analysis system OYE, System, Test, Flow cytometric reagents and accessories GKL Hemoglobin assay JPK, Analyte Controls, Hematology Quality Control 4. Panel: Hematology (81) Immunology (82) H. Intended Use: 1. Intended use(s): Instrument BD FACSPresto™ System BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. • For use with the BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 of lymphocyte, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. Device BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. 3 • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. BD Multi-Check Control The BD Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. BD Multi-Check CD4 Low Control The BD Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto system, an imaging cytometer. Eurotrol FACSPresto Hb Control Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the FACSPresto System. 2. Indication(s) for use: Same as above 3. Special conditions for use statement(s): For Prescription Use Only 4. Special instrument requirements: BD FACSPresto™ System instrument I. Device Description: The device consists of the BD FACSPresto system, the BD FACSPresto CD4/Hb Cartridge, and the BD FACSPresto CD4/Hb Cartridge Kit. 4 BD FACSPresto System This instrument is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer with integrated BD FACSPresto System Software. BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Cartridge contains antibody-fluorochrome conjugates, CD4 PE- Cy5, CD3 APC, CD45RA-APC, and CD 14-PE, dried on a reagent disc and is embedded with reagent quality controls. Transfer Pipettes BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Finger Stick Sample Collection Kit (including lancets, alcohol pads, sponges, and bandages) The BD FACSPresto System (instrument) includes a power supply, adapter cords, instrument cover, a sample incubation work station, printer paper and a USB flash drive. BD Multi-Check Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium BD Multi-Check CD4 Low Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium Eurotrol FACSPresto Hb Control Levels 1−3 Process control composed of purified bovine hemolysate J. Substantial Equivalence Information: 1. Predicate device name(s): a. BD FACSCalibur using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes b. Sysmex Automated Hematology Analyzer KX-21N c. R&D Systems Whole Blood Flow Control, also known as StatusFlow d. StatusFlow Lo e. Eurotrol Hb 301 Control (Levels 1−3) 2. Predicate 510(k) number(s): a. K071141 b. K981761 c. K961610, BK990005 d. K982231 e. BK030067 3. Comparison with predicate: 5 Instrument Similarities and Differences Item Device BD FACSPresto System Predicate BD FACSCalibur Intended Use BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and /or measurement of absorbance spectrums. For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510−545 nm, 562−607 nm, and >650 nm • For use in erythrocyte-lysed whole peripheral blood • For use with or without isotype control • To characterize and monitor some forms of autoimmune disease • To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals Instrument Setup and Quality Control Setup: Automated instrument setup. Instrument QC: automated verification of instrument performance at power- on-self-test (POST) and during cartridge runs. Cartridge QC: rat anti-mouse antibodies bound to polystyrene beads confirm presence of sample and reagent. Setup: Semi-automated setup using BD FACSComp software with BD Calibrite beads for setting PMT voltages, fluorescence compensation, and checking instrument sensitivity. Software Integrated BD FACSPresto System Software Integrated software on instrument and BD MultiSet Software on external computer Optics Fluorescence excitation of stained cells in microfluidic channel by LED illumination; Fluorescence emission measured by CCD camera imaging Fluorescence excitation of stained cells in flow stream by laser illumination; Fluorescence emission measured by PMTs Cytometry Imaging Flow 6 Absolute CD4 Count and %CD4 Assays Similarities Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Results Reporting • Absolute CD4 count (cells/µL) • %CD4 (the percentage of CD4 positive lymphocytes counted within the total lymphocyte population count) Same Sample Type Whole blood Same Differences Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Intended Use/ Indications for Use BD FACSPrest Measurand:

idK150815_s0_e2000

K150815.txt

type of test

Quantitative test for CD4% and CD4 absolute count by cytometry imaging and quantitative test for hemoglobin by absorbance spectrometer

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150815 B. Purpose for Submission: New assay and instrument C. Measurand: Lymphocyte CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin concentration D. Type of Test: Quantitative test for CD4% and CD4 absolute count by cytometry imaging and quantitative test for hemoglobin by absorbance spectrometer E. Applicant: BD Biosciences F. Proprietary and Established Names: BD FACSPresto™ System BD FACSPresto™ CD4/Hb Cartridge BD FACSPresto™ CD4/Hb Cartridge Kit BD Multi-Check Control BD Multi-Check CD4 Low Control Eurotrol FACSPresto Hb Control (Levels 1−3) G. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 21 CFR §864.8625, Hematology Quality Control Mixture 2. Classification: 2 Class II (assay) Class II (controls) 3. Product code: PMG, Automated multicolor fluorescent imaging cytometric analysis system OYE, System, Test, Flow cytometric reagents and accessories GKL Hemoglobin assay JPK, Analyte Controls, Hematology Quality Control 4. Panel: Hematology (81) Immunology (82) H. Intended Use: 1. Intended use(s): Instrument BD FACSPresto™ System BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. • For use with the BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 of lymphocyte, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. Device BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. 3 • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. BD Multi-Check Control The BD Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. BD Multi-Check CD4 Low Control The BD Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto system, an imaging cytometer. Eurotrol FACSPresto Hb Control Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the FACSPresto System. 2. Indication(s) for use: Same as above 3. Special conditions for use statement(s): For Prescription Use Only 4. Special instrument requirements: BD FACSPresto™ System instrument I. Device Description: The device consists of the BD FACSPresto system, the BD FACSPresto CD4/Hb Cartridge, and the BD FACSPresto CD4/Hb Cartridge Kit. 4 BD FACSPresto System This instrument is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer with integrated BD FACSPresto System Software. BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Cartridge contains antibody-fluorochrome conjugates, CD4 PE- Cy5, CD3 APC, CD45RA-APC, and CD 14-PE, dried on a reagent disc and is embedded with reagent quality controls. Transfer Pipettes BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Finger Stick Sample Collection Kit (including lancets, alcohol pads, sponges, and bandages) The BD FACSPresto System (instrument) includes a power supply, adapter cords, instrument cover, a sample incubation work station, printer paper and a USB flash drive. BD Multi-Check Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium BD Multi-Check CD4 Low Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium Eurotrol FACSPresto Hb Control Levels 1−3 Process control composed of purified bovine hemolysate J. Substantial Equivalence Information: 1. Predicate device name(s): a. BD FACSCalibur using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes b. Sysmex Automated Hematology Analyzer KX-21N c. R&D Systems Whole Blood Flow Control, also known as StatusFlow d. StatusFlow Lo e. Eurotrol Hb 301 Control (Levels 1−3) 2. Predicate 510(k) number(s): a. K071141 b. K981761 c. K961610, BK990005 d. K982231 e. BK030067 3. Comparison with predicate: 5 Instrument Similarities and Differences Item Device BD FACSPresto System Predicate BD FACSCalibur Intended Use BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and /or measurement of absorbance spectrums. For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510−545 nm, 562−607 nm, and >650 nm • For use in erythrocyte-lysed whole peripheral blood • For use with or without isotype control • To characterize and monitor some forms of autoimmune disease • To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals Instrument Setup and Quality Control Setup: Automated instrument setup. Instrument QC: automated verification of instrument performance at power- on-self-test (POST) and during cartridge runs. Cartridge QC: rat anti-mouse antibodies bound to polystyrene beads confirm presence of sample and reagent. Setup: Semi-automated setup using BD FACSComp software with BD Calibrite beads for setting PMT voltages, fluorescence compensation, and checking instrument sensitivity. Software Integrated BD FACSPresto System Software Integrated software on instrument and BD MultiSet Software on external computer Optics Fluorescence excitation of stained cells in microfluidic channel by LED illumination; Fluorescence emission measured by CCD camera imaging Fluorescence excitation of stained cells in flow stream by laser illumination; Fluorescence emission measured by PMTs Cytometry Imaging Flow 6 Absolute CD4 Count and %CD4 Assays Similarities Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Results Reporting • Absolute CD4 count (cells/µL) • %CD4 (the percentage of CD4 positive lymphocytes counted within the total lymphocyte population count) Same Sample Type Whole blood Same Differences Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Intended Use/ Indications for Use BD FACSPrest Type of test:

idK150815_s0_e2000

K150815.txt

indications for use

Same as above

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150815 B. Purpose for Submission: New assay and instrument C. Measurand: Lymphocyte CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin concentration D. Type of Test: Quantitative test for CD4% and CD4 absolute count by cytometry imaging and quantitative test for hemoglobin by absorbance spectrometer E. Applicant: BD Biosciences F. Proprietary and Established Names: BD FACSPresto™ System BD FACSPresto™ CD4/Hb Cartridge BD FACSPresto™ CD4/Hb Cartridge Kit BD Multi-Check Control BD Multi-Check CD4 Low Control Eurotrol FACSPresto Hb Control (Levels 1−3) G. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 21 CFR §864.8625, Hematology Quality Control Mixture 2. Classification: 2 Class II (assay) Class II (controls) 3. Product code: PMG, Automated multicolor fluorescent imaging cytometric analysis system OYE, System, Test, Flow cytometric reagents and accessories GKL Hemoglobin assay JPK, Analyte Controls, Hematology Quality Control 4. Panel: Hematology (81) Immunology (82) H. Intended Use: 1. Intended use(s): Instrument BD FACSPresto™ System BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. • For use with the BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 of lymphocyte, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. Device BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. 3 • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. BD Multi-Check Control The BD Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. BD Multi-Check CD4 Low Control The BD Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto system, an imaging cytometer. Eurotrol FACSPresto Hb Control Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the FACSPresto System. 2. Indication(s) for use: Same as above 3. Special conditions for use statement(s): For Prescription Use Only 4. Special instrument requirements: BD FACSPresto™ System instrument I. Device Description: The device consists of the BD FACSPresto system, the BD FACSPresto CD4/Hb Cartridge, and the BD FACSPresto CD4/Hb Cartridge Kit. 4 BD FACSPresto System This instrument is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer with integrated BD FACSPresto System Software. BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Cartridge contains antibody-fluorochrome conjugates, CD4 PE- Cy5, CD3 APC, CD45RA-APC, and CD 14-PE, dried on a reagent disc and is embedded with reagent quality controls. Transfer Pipettes BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Finger Stick Sample Collection Kit (including lancets, alcohol pads, sponges, and bandages) The BD FACSPresto System (instrument) includes a power supply, adapter cords, instrument cover, a sample incubation work station, printer paper and a USB flash drive. BD Multi-Check Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium BD Multi-Check CD4 Low Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium Eurotrol FACSPresto Hb Control Levels 1−3 Process control composed of purified bovine hemolysate J. Substantial Equivalence Information: 1. Predicate device name(s): a. BD FACSCalibur using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes b. Sysmex Automated Hematology Analyzer KX-21N c. R&D Systems Whole Blood Flow Control, also known as StatusFlow d. StatusFlow Lo e. Eurotrol Hb 301 Control (Levels 1−3) 2. Predicate 510(k) number(s): a. K071141 b. K981761 c. K961610, BK990005 d. K982231 e. BK030067 3. Comparison with predicate: 5 Instrument Similarities and Differences Item Device BD FACSPresto System Predicate BD FACSCalibur Intended Use BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and /or measurement of absorbance spectrums. For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510−545 nm, 562−607 nm, and >650 nm • For use in erythrocyte-lysed whole peripheral blood • For use with or without isotype control • To characterize and monitor some forms of autoimmune disease • To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals Instrument Setup and Quality Control Setup: Automated instrument setup. Instrument QC: automated verification of instrument performance at power- on-self-test (POST) and during cartridge runs. Cartridge QC: rat anti-mouse antibodies bound to polystyrene beads confirm presence of sample and reagent. Setup: Semi-automated setup using BD FACSComp software with BD Calibrite beads for setting PMT voltages, fluorescence compensation, and checking instrument sensitivity. Software Integrated BD FACSPresto System Software Integrated software on instrument and BD MultiSet Software on external computer Optics Fluorescence excitation of stained cells in microfluidic channel by LED illumination; Fluorescence emission measured by CCD camera imaging Fluorescence excitation of stained cells in flow stream by laser illumination; Fluorescence emission measured by PMTs Cytometry Imaging Flow 6 Absolute CD4 Count and %CD4 Assays Similarities Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Results Reporting • Absolute CD4 count (cells/µL) • %CD4 (the percentage of CD4 positive lymphocytes counted within the total lymphocyte population count) Same Sample Type Whole blood Same Differences Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Intended Use/ Indications for Use BD FACSPrest Indications for use:

idK150815_s0_e2000

K150815.txt

applicant

BD Biosciences

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150815 B. Purpose for Submission: New assay and instrument C. Measurand: Lymphocyte CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin concentration D. Type of Test: Quantitative test for CD4% and CD4 absolute count by cytometry imaging and quantitative test for hemoglobin by absorbance spectrometer E. Applicant: BD Biosciences F. Proprietary and Established Names: BD FACSPresto™ System BD FACSPresto™ CD4/Hb Cartridge BD FACSPresto™ CD4/Hb Cartridge Kit BD Multi-Check Control BD Multi-Check CD4 Low Control Eurotrol FACSPresto Hb Control (Levels 1−3) G. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 21 CFR §864.8625, Hematology Quality Control Mixture 2. Classification: 2 Class II (assay) Class II (controls) 3. Product code: PMG, Automated multicolor fluorescent imaging cytometric analysis system OYE, System, Test, Flow cytometric reagents and accessories GKL Hemoglobin assay JPK, Analyte Controls, Hematology Quality Control 4. Panel: Hematology (81) Immunology (82) H. Intended Use: 1. Intended use(s): Instrument BD FACSPresto™ System BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. • For use with the BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 of lymphocyte, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. Device BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. 3 • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. BD Multi-Check Control The BD Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. BD Multi-Check CD4 Low Control The BD Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto system, an imaging cytometer. Eurotrol FACSPresto Hb Control Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the FACSPresto System. 2. Indication(s) for use: Same as above 3. Special conditions for use statement(s): For Prescription Use Only 4. Special instrument requirements: BD FACSPresto™ System instrument I. Device Description: The device consists of the BD FACSPresto system, the BD FACSPresto CD4/Hb Cartridge, and the BD FACSPresto CD4/Hb Cartridge Kit. 4 BD FACSPresto System This instrument is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer with integrated BD FACSPresto System Software. BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Cartridge contains antibody-fluorochrome conjugates, CD4 PE- Cy5, CD3 APC, CD45RA-APC, and CD 14-PE, dried on a reagent disc and is embedded with reagent quality controls. Transfer Pipettes BD FACSPresto CD4/Hb Cartridge Kit BD FACSPresto CD4/Hb Cartridge BD FACSPresto CD4/Hb Finger Stick Sample Collection Kit (including lancets, alcohol pads, sponges, and bandages) The BD FACSPresto System (instrument) includes a power supply, adapter cords, instrument cover, a sample incubation work station, printer paper and a USB flash drive. BD Multi-Check Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium BD Multi-Check CD4 Low Control Process control composed of human leukocytes and erythrocytes in a stabilizing medium Eurotrol FACSPresto Hb Control Levels 1−3 Process control composed of purified bovine hemolysate J. Substantial Equivalence Information: 1. Predicate device name(s): a. BD FACSCalibur using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes b. Sysmex Automated Hematology Analyzer KX-21N c. R&D Systems Whole Blood Flow Control, also known as StatusFlow d. StatusFlow Lo e. Eurotrol Hb 301 Control (Levels 1−3) 2. Predicate 510(k) number(s): a. K071141 b. K981761 c. K961610, BK990005 d. K982231 e. BK030067 3. Comparison with predicate: 5 Instrument Similarities and Differences Item Device BD FACSPresto System Predicate BD FACSCalibur Intended Use BD FACSPresto™ System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and /or measurement of absorbance spectrums. For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510−545 nm, 562−607 nm, and >650 nm • For use in erythrocyte-lysed whole peripheral blood • For use with or without isotype control • To characterize and monitor some forms of autoimmune disease • To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals Instrument Setup and Quality Control Setup: Automated instrument setup. Instrument QC: automated verification of instrument performance at power- on-self-test (POST) and during cartridge runs. Cartridge QC: rat anti-mouse antibodies bound to polystyrene beads confirm presence of sample and reagent. Setup: Semi-automated setup using BD FACSComp software with BD Calibrite beads for setting PMT voltages, fluorescence compensation, and checking instrument sensitivity. Software Integrated BD FACSPresto System Software Integrated software on instrument and BD MultiSet Software on external computer Optics Fluorescence excitation of stained cells in microfluidic channel by LED illumination; Fluorescence emission measured by CCD camera imaging Fluorescence excitation of stained cells in flow stream by laser illumination; Fluorescence emission measured by PMTs Cytometry Imaging Flow 6 Absolute CD4 Count and %CD4 Assays Similarities Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Results Reporting • Absolute CD4 count (cells/µL) • %CD4 (the percentage of CD4 positive lymphocytes counted within the total lymphocyte population count) Same Sample Type Whole blood Same Differences Item Device BD FACSPresto System for use with BD FACSPresto CD4/Hb Cartridge and BD FACSPresto CD4/Hb Cartridge Kit Predicate BD FACSCalibur using BD Tritest CD3/CD4/ CD45 with BD Trucount Tubes (K071141) Intended Use/ Indications for Use BD FACSPrest Applicant:

idK150815_s14000_e16000

K150815.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

Control: BD Multi-Check Control and BD Multi-Check CD4 Low Control are assayed whole blood quality control products for analysis using monoclonal antibody reagents and image cytometry. They provide positive cell controls that are processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. Eurotrol FACSPresto Hb Control is an assayed hemoglobin control product for analysis using spectrophotometry. The control is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. P. Other Supportive Instrument Performance Characteristics Data Not Covered In the “Performance Characteristics” Section above: 29 Comparison of Traditional gating and CD3+CD45RA single color gating strategy for determination of total lymphocytes: #Events acquired in total, in the CD45 gate, CD3+CD45RA gate and in both gates Sample All events CD45+ CD3+CD45RA+ CD3+CD45RA+CD45+ 1 32705 7711 7741 7662 2 16305 6356 6319 6286 3 25577 11449 11433 11262 4 37034 13131 13054 12999 5 33982 15866 15817 15724 Note: events are not per µL Fifty seven (57) samples were analyzed, comprised of 18 HIV- samples and 39 HIV+ samples on two different BD FACSPresto systems: a BD FACSCalibur instrument with BD Tritest CD3/4/45 (the predicate assay), and a BD FACSCalibur instrument with the BD Multitest Immune Monitoring Kit (IMK) consisting of CD3/4/8/45 and CD3/16+56/19/45 (2 tube T/B/NK assay), to compare total lymphocyte counts between methods. The Tritest assay uses SSC and CD45 signals to identify lymphocytes as SSC low and CD45 high. The IMK assay similarly uses SSC and CD45 to identify lymphocytes and then uses CD3, CD19 and CD16+CD56 to identify these lymphocytes as T-cells, B-cells and NK-cells respectively. Both FACSCalibur methods used BD Trucount beads for calculating absolute lymphocyte counts. Lymphocytes/µL Presto vs. Tritest Presto vs. IMK Presto vs. Tritest (MC) N 57 57 717 Sample Range 656−4530 701−4486 225−11883 Slope 0.96 1.01 0.93 Slope 95% CI 0.91 to 1.01 0.97 to 1.05 0.92 to 0.95 Intercept 113.3 24.3 13.15 R2 0.97 0.98 0.99 Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK150815_s14000_e16000

K150815.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

. Quality Control: BD Multi-Check Control and BD Multi-Check CD4 Low Control are assayed whole blood quality control products for analysis using monoclonal antibody reagents and image cytometry. They provide positive cell controls that are processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. Eurotrol FACSPresto Hb Control is an assayed hemoglobin control product for analysis using spectrophotometry. The control is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. P. Other Supportive Instrument Performance Characteristics Data Not Covered In the “Performance Characteristics” Section above: 29 Comparison of Traditional gating and CD3+CD45RA single color gating strategy for determination of total lymphocytes: #Events acquired in total, in the CD45 gate, CD3+CD45RA gate and in both gates Sample All events CD45+ CD3+CD45RA+ CD3+CD45RA+CD45+ 1 32705 7711 7741 7662 2 16305 6356 6319 6286 3 25577 11449 11433 11262 4 37034 13131 13054 12999 5 33982 15866 15817 15724 Note: events are not per µL Fifty seven (57) samples were analyzed, comprised of 18 HIV- samples and 39 HIV+ samples on two different BD FACSPresto systems: a BD FACSCalibur instrument with BD Tritest CD3/4/45 (the predicate assay), and a BD FACSCalibur instrument with the BD Multitest Immune Monitoring Kit (IMK) consisting of CD3/4/8/45 and CD3/16+56/19/45 (2 tube T/B/NK assay), to compare total lymphocyte counts between methods. The Tritest assay uses SSC and CD45 signals to identify lymphocytes as SSC low and CD45 high. The IMK assay similarly uses SSC and CD45 to identify lymphocytes and then uses CD3, CD19 and CD16+CD56 to identify these lymphocytes as T-cells, B-cells and NK-cells respectively. Both FACSCalibur methods used BD Trucount beads for calculating absolute lymphocyte counts. Lymphocytes/µL Presto vs. Tritest Presto vs. IMK Presto vs. Tritest (MC) N 57 57 717 Sample Range 656−4530 701−4486 225−11883 Slope 0.96 1.01 0.93 Slope 95% CI 0.91 to 1.01 0.97 to 1.05 0.92 to 0.95 Intercept 113.3 24.3 13.15 R2 0.97 0.98 0.99 Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK183324_s0_e2000

K183324.txt

purpose for submission

To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Purpose for submission:

idK183324_s0_e2000

K183324.txt

measurand

Omadacycline in the dilution range of 0.008 – 32 µg/mL.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Measurand:

idK183324_s0_e2000

K183324.txt

type of test

Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Type of test:

idK183324_s0_e2000

K183324.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Classification:

idK183324_s0_e2000

K183324.txt

panel

83, Microbiology

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Panel:

idK183324_s0_e2000

K183324.txt

intended use

The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Intended use:

idK183324_s0_e2000

K183324.txt

predicate device name

Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Predicate device name:

idK183324_s0_e2000

K183324.txt

applicant

ThermoFisher Scientific

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Applicant:

idK183324_s0_e2000

K183324.txt

regulation section

866.1640 Antimicrobial Susceptibility Test Powder

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183324 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Omadacycline at concentrations of 0.008 – 32 µg/mL to the Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System for testing H. influenzae and Streptococcus spp. C. Measurand: Omadacycline in the dilution range of 0.008 – 32 µg/mL. D. Type of Test: Quantitative Antimicrobial Susceptibility Test (AST), growth-based detection E. Applicant: ThermoFisher Scientific F. Proprietary and Established Names: Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 µg/mL G. Regulatory Information: 1. Regulation section: 866.1640 Antimicrobial Susceptibility Test Powder 2. Classification: Class II 3. Product code: 2 JWY – Manual Antimicrobial Susceptibility Test System LRG – Instrument for Auto Reader and Instrumentation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial 4. Panel: 83, Microbiology H. Intended Use: 1. Intended use(s): The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. 2. Indication(s) for use: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Omadacycline in the dilution range of 0.008 - 32 µg/mL for testing Streptococcus spp. and Haemophilus influenzae on the Sensititre 20 - 24 hour MIC panel. Omadacycline has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus pneumoniae Haemophilus influenzae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus pyogenes 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the labeling: The testing of omadacycline with Streptococcus spp. was performed using the AutoReader (OptiRead) and VIZION reading methods and Haemophilus influenzae was only read by VIZION manual method. The use of an alternative 3 reading method when testing omadacycline has not been evaluated. The ability of the Sensititre system to detect resistance to Omadacycline in the following species is unknown because resistant strains were not available at the time of comparative testing: H. influenzae, S. pneumoniae, S. pyogenes, and S. anginosus. Isolates yielding omadacycline MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory for further testing. The performance of Omadacycline with Haemophilus influenzae and Streptococcus spp. was performed using the AIM autoinoculator. The use of an alternative inoculation system when testing Omadacycline has not been evaluated. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing S. pyogenes and S. pneumoniae with both OptiRead and VIZION reading methods compared to the CLSI reference broth microdilution. MIC values MIC values tended to be in exact agreement or one dilution higher when testing S. anginosus with both OptiRead and VIZION. Omadacycline MIC values tended to be in exact agreement or at least one dilution lower when testing H. influenzae with the VIZION only. 4. Special instrument requirements: Sensititre AIM for device inoculation Sensititre VIZION or OptiRead for plate reading I. Device Description: Sensititre MIC Susceptibility MIC panels are multi-well microtiter plates, dosed with dried, stabilized antimicrobials. It is a miniaturized version of the classic broth dilution method and can provide both qualitative and quantitative susceptibility results. After inoculation, plates are sealed with an adhesive seal, incubated at 34 – 36 °C for 20 – 24 hours and examined for bacterial growth. Antimicrobial susceptibility test results can be determined by reading growth using the digital viewing device (VIZION) or automatically on an autoreader (OptiRead) using fluorescence. J. Substantial Equivalence Information: 1. Predicate device name(s): Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates 2. Predicate 510(k) number(s): 4 K040846 3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183324 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Omadacycline Predicate K040846 Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Ertapenem Intended Use The Sensititre Haemophilus influenzae/Streptococcus pneumoniae plates are in vitro diagnostic products for clinical susceptibility testing of Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus species. Same Test Panel 96 well plate is dosed with selected antimicrobial agents and substrate for the fluorescent reads, then dried. The bacterial suspension in the appropriate broth is used to rehydrate the plate. Same Test Organism Haemophilus influenzae, Streptococcus pneumoniae, and Streptococcus spp. Same Reading Methods for Streptococcus spp Results can be read using the following methods: 1) Automatically with the OptiRead (fluorescent substrate technology) 2) On the VIZION (digital viewing device) Same Reading Methods for H. influenzae Results can be read using the VIZION (digital viewing device) only Same Incubation 20-24 hours, 35 ± 1° C Same Inoculation media CAMHBT + LHB (Streptococcus spp.), HTM broth (H. influenzae) Same 5 Differences Item Device Predicate Antimicrobial Agent Omadacycline Cefepime Concentration Range 0.008 – 32 µg/mL 0.008 – 16 µg/mL K. Standard/Guidance Document Referenced (if applicable): Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems – August 28, 2009. CLSI M100-S027: Performance Standards for Antimicrobial Susceptibility Testing; Twenty- Seventh Informational Supplement CLSI M7-A10: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition L. Test Principle: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae system includes multi-well plastic microtiter plates that contain doubled dilution of antibacterial agents. Each plate includes antimicrobial agents at appropriate dilutions. Results can be read by the digital device, VIZION, or by use of an automated reader, OptiRead (Streptococcus spp. only). The VIZION allows the panel image to be displayed on a touch screen directly from a video camera and allows the user to visually determine MIC results. The Sensititre OptiRead utilizes fluorescence technology to read the microbroth dilution plates after 20 to 24 hours incubation. The technology involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a fluorogenic substrate. The substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond which prevents fluorescence. The enzymatic action of the bacterial surface enzymes on the substrate cleaves the bond releasing fluorescence. The amount of fluorescence detected is directly related to bacterial growth. The MIC is determined by observing the lowest dilution of antimicrobial agent that inhibits growth of the organism. The substrate can be added to the inoculum broth which is dispensed into the test plate at the same time as the test organism, or, the plates can be prepared with the substrate already added to each micro-well. 6 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A reproducibility study was performed at four sites using a panel comprised of 8 isolates of Streptococcus Regulation section:

idK183324_s6000_e8000

K183324.txt

proposed labeling

The labeling supports the finding of substantial equivalence for this device.

25 ≥0.5 S. pneumoniae CABP ≤0.12 0.25 ≥0.5 1S. anginosus group includes S. anginosus, S. intermedius, and S. constellatus. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK183324_s6000_e8000

K183324.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

0.25 ≥0.5 S. pneumoniae CABP ≤0.12 0.25 ≥0.5 1S. anginosus group includes S. anginosus, S. intermedius, and S. constellatus. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK151917_s0_e2000

K151917.txt

purpose for submission

New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex Corporation, ARIES® System D. Type of Test or Tests Performed: Nucleic-acid amplification testing E. System Descriptions: 1. Device Description: The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. The instrument system is used with specific IVD assays to measure multiple analytes. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals. The ARIES® System is for in vitro diagnostic use by trained laboratory professionals in a controlled laboratory environment and is not intended for patient contact. The ARIES® System consists of the following; · a bench top instrument with two separate modules each with a magazine rack to accommodate six disposable single-use assay cassettes · methods for manipulating sample and reagent movement within the cassette · heaters for lysis, elution and nucleic acid amplification · 6 optical channels · fluorometer for real-time PCR fluorescence detection and melt analysis · methods for thermal and optical calibration · software for running and analyzing IVD assays 2. Principles of Operation: a. Device Features Controlled by Software: 2 The ARIES® SYSTEM instrument uses the ARIES® Software 1.0 software and the ARIES® Assay Protocol file for data acquisition, analysis, and reporting. The ARIES® instrument software is installed on the embedded PC and controls the two modules housed in the instrument. The ARIES® Instrument is a Real Time PCR Instrument. The ARIES® instrument software provides the interface between the ARIES® Software 1.0 and the ARIES® system hardware. The ARIES® system software communicates to the instrument software to manage operations of the system, including manipulation of sample and reagent movement within the cassette, control of heaters for lysis, elution and nucleic acid amplification, controlling the fluorimeter for real-time PCR bulk fluorescence detection and melt analysis, controlling thermal and optical calibration and data analysis for IVD assays run on the system. The ARIES® Software 1.0 software is installed in an embedded computer and provides the graphical user interface (GUI) application that is intended to be the end- user interface to the ARIES® instrument. The ARIES® Software 1.0 software is responsible for providing the environment in which an end-user runs and reports assays, administers, maintains, and sets default settings for the system. The ARIES® Assay Protocol Software is a framework that allows running assays and generating reports on an ARIES® instrument. The ARIES® Assay Protocol Software is contained within an assay protocol template. This template is a read-only type of assay protocol file that contains a specific script, data reduction, assay editor tool, and reports, and default assay parameters and blank call logic. The ARIES® Assay Protocol file that is generated contains assay logic (rules that specify clinical outcomes), data reduction runtime files (DLL), and assay configuration parameters (script parameters that control the instrument for running a sample in a cassette and data reduction algorithm parameters). b. Operational Environment (Off-the-Shelf Software): The ARIES® Software 1.0 software uses some commercial off-the-shelf software components. The sponsor provided detailed documentation for the OTS used, including validation, for both the ARIES® Software 1.0 software and the ARIES® Assay Protocol Software. For the ARIES® Assay Protocol Software used by Luminex, the recommended configuration for each computer is: • Windows 7 Professional SP1 (US English, 32 bit or 64 bit) • 2.8 GHz Intel Dual Core (or higher) • 4 Gb RAM (or higher) • 160 GB hard drive (or higher) The programming language used to develop the ARIES® Software 1.0 software was 3 Microsoft Visual C#. Instrument control software was written in a combination and C# and C++. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___x_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___x_____ 4. Specimen Identification: A barcode reader may be used for entry of sample IDs, or they may be entered manually. 5. Specimen Sampling and Handling: Samples are manually prepared according to assay manufacturer’s suggestions and are transferred to an assay specific cassette for analysis. 6. Calibration: Calibration is performed by Luminex service personnel using ARIES® System Verification Cassettes. 7. Quality Control: Each ARIES® assay cassette includes a Sample Process Control (SPC). The SPC has a known melting temperature (Tm) range and cycle threshold (Ct) range. Each time an assay is run, the system measures the temperature and fluorescence intensity of the SPC control to ensure the thermal and optical subsystems have remained in calibration. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes_____x___ or No________ 4 F. Regulatory Information: 1. Regulation section: 21 CFR 862.2570 Instrumentation for clinical multiplex test systems 2. Classification: Class II (special controls) 3 Product code: OOI – Real-time nucleic acid amplification 4. Panel: Chemistry (75) G. Intended Use: 1. Indication(s) for Use: The Luminex ARIES® System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: BD Diagnostics (Becton, Dickinson and Company), BD MAX System K111860 2. Comparison with Predicate Device: Similarities Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) Intended Use The Luminex ARIES® System is an in vitro Same 5 Similarities Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence- based PCR. Sample Preparation Method Automated nucleic acid lysis and extraction by the ARIES® system Same Assay Format Amplification: Real Time PCR Detection: Fluorgenic Same Interpretation of Test Results Automated (Diagnostic software of Luminex ARIES® System) Same Differences Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) Fluidics Self-contained Manual sample preparation Assay Cartridge · Cartridge is closed to the environment · Single Use · Reagent strips are open to the environment · Can be used twice Fluorescence Channels Six (6) channels Five (5) channels Software Software resides on the ARIES® System Software resides on an all- in-one computer I. Special Control/Guidance Document Referenced (if applicable): · IEC60825 – Safety of laser products, 2nd edition, 2007 · IEC62304, - Medical Device Software – Software Life Cycle Processes, 2006 · ISO 14971 – Medical Devices – Applications of Risk Management, 2007 · ISO15223-1 – Medical Devices – Symbols to be used with Medical Device Labels, Labelling, and Information to be Supplied, 2007 6 J. Performance Characteristics: 1. Analytical Performance: Performance for the ARIES® System was established in the clearance of the assay, the ARIES® HSV1&2 Assay (k151906). a. Accuracy: See k151906 b. Precision/Reproducibility: See k151906 c. Linearity: See k151906 d. Carryover: See k151906 e. Interfering Substances: See k151906 2. Other Supportive Instrument Performance Data Not Covered Above: Not applicable K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Purpose for submission:

idK151917_s0_e2000

K151917.txt

type of test

Nucleic-acid amplification testing

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex Corporation, ARIES® System D. Type of Test or Tests Performed: Nucleic-acid amplification testing E. System Descriptions: 1. Device Description: The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. The instrument system is used with specific IVD assays to measure multiple analytes. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals. The ARIES® System is for in vitro diagnostic use by trained laboratory professionals in a controlled laboratory environment and is not intended for patient contact. The ARIES® System consists of the following; · a bench top instrument with two separate modules each with a magazine rack to accommodate six disposable single-use assay cassettes · methods for manipulating sample and reagent movement within the cassette · heaters for lysis, elution and nucleic acid amplification · 6 optical channels · fluorometer for real-time PCR fluorescence detection and melt analysis · methods for thermal and optical calibration · software for running and analyzing IVD assays 2. Principles of Operation: a. Device Features Controlled by Software: 2 The ARIES® SYSTEM instrument uses the ARIES® Software 1.0 software and the ARIES® Assay Protocol file for data acquisition, analysis, and reporting. The ARIES® instrument software is installed on the embedded PC and controls the two modules housed in the instrument. The ARIES® Instrument is a Real Time PCR Instrument. The ARIES® instrument software provides the interface between the ARIES® Software 1.0 and the ARIES® system hardware. The ARIES® system software communicates to the instrument software to manage operations of the system, including manipulation of sample and reagent movement within the cassette, control of heaters for lysis, elution and nucleic acid amplification, controlling the fluorimeter for real-time PCR bulk fluorescence detection and melt analysis, controlling thermal and optical calibration and data analysis for IVD assays run on the system. The ARIES® Software 1.0 software is installed in an embedded computer and provides the graphical user interface (GUI) application that is intended to be the end- user interface to the ARIES® instrument. The ARIES® Software 1.0 software is responsible for providing the environment in which an end-user runs and reports assays, administers, maintains, and sets default settings for the system. The ARIES® Assay Protocol Software is a framework that allows running assays and generating reports on an ARIES® instrument. The ARIES® Assay Protocol Software is contained within an assay protocol template. This template is a read-only type of assay protocol file that contains a specific script, data reduction, assay editor tool, and reports, and default assay parameters and blank call logic. The ARIES® Assay Protocol file that is generated contains assay logic (rules that specify clinical outcomes), data reduction runtime files (DLL), and assay configuration parameters (script parameters that control the instrument for running a sample in a cassette and data reduction algorithm parameters). b. Operational Environment (Off-the-Shelf Software): The ARIES® Software 1.0 software uses some commercial off-the-shelf software components. The sponsor provided detailed documentation for the OTS used, including validation, for both the ARIES® Software 1.0 software and the ARIES® Assay Protocol Software. For the ARIES® Assay Protocol Software used by Luminex, the recommended configuration for each computer is: • Windows 7 Professional SP1 (US English, 32 bit or 64 bit) • 2.8 GHz Intel Dual Core (or higher) • 4 Gb RAM (or higher) • 160 GB hard drive (or higher) The programming language used to develop the ARIES® Software 1.0 software was 3 Microsoft Visual C#. Instrument control software was written in a combination and C# and C++. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___x_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___x_____ 4. Specimen Identification: A barcode reader may be used for entry of sample IDs, or they may be entered manually. 5. Specimen Sampling and Handling: Samples are manually prepared according to assay manufacturer’s suggestions and are transferred to an assay specific cassette for analysis. 6. Calibration: Calibration is performed by Luminex service personnel using ARIES® System Verification Cassettes. 7. Quality Control: Each ARIES® assay cassette includes a Sample Process Control (SPC). The SPC has a known melting temperature (Tm) range and cycle threshold (Ct) range. Each time an assay is run, the system measures the temperature and fluorescence intensity of the SPC control to ensure the thermal and optical subsystems have remained in calibration. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes_____x___ or No________ 4 F. Regulatory Information: 1. Regulation section: 21 CFR 862.2570 Instrumentation for clinical multiplex test systems 2. Classification: Class II (special controls) 3 Product code: OOI – Real-time nucleic acid amplification 4. Panel: Chemistry (75) G. Intended Use: 1. Indication(s) for Use: The Luminex ARIES® System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: BD Diagnostics (Becton, Dickinson and Company), BD MAX System K111860 2. Comparison with Predicate Device: Similarities Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) Intended Use The Luminex ARIES® System is an in vitro Same 5 Similarities Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence- based PCR. Sample Preparation Method Automated nucleic acid lysis and extraction by the ARIES® system Same Assay Format Amplification: Real Time PCR Detection: Fluorgenic Same Interpretation of Test Results Automated (Diagnostic software of Luminex ARIES® System) Same Differences Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) Fluidics Self-contained Manual sample preparation Assay Cartridge · Cartridge is closed to the environment · Single Use · Reagent strips are open to the environment · Can be used twice Fluorescence Channels Six (6) channels Five (5) channels Software Software resides on the ARIES® System Software resides on an all- in-one computer I. Special Control/Guidance Document Referenced (if applicable): · IEC60825 – Safety of laser products, 2nd edition, 2007 · IEC62304, - Medical Device Software – Software Life Cycle Processes, 2006 · ISO 14971 – Medical Devices – Applications of Risk Management, 2007 · ISO15223-1 – Medical Devices – Symbols to be used with Medical Device Labels, Labelling, and Information to be Supplied, 2007 6 J. Performance Characteristics: 1. Analytical Performance: Performance for the ARIES® System was established in the clearance of the assay, the ARIES® HSV1&2 Assay (k151906). a. Accuracy: See k151906 b. Precision/Reproducibility: See k151906 c. Linearity: See k151906 d. Carryover: See k151906 e. Interfering Substances: See k151906 2. Other Supportive Instrument Performance Data Not Covered Above: Not applicable K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Type of test:

idK151917_s0_e2000

K151917.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE A. 510(k) Number: k151917 B. Purpose for Submission: New instrument for use with the ARIES® HSV 1&2 Assay cleared under k151906 C. Manufacturer and Instrument Name: Luminex Corporation, ARIES® System D. Type of Test or Tests Performed: Nucleic-acid amplification testing E. System Descriptions: 1. Device Description: The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. The instrument system is used with specific IVD assays to measure multiple analytes. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals. The ARIES® System is for in vitro diagnostic use by trained laboratory professionals in a controlled laboratory environment and is not intended for patient contact. The ARIES® System consists of the following; · a bench top instrument with two separate modules each with a magazine rack to accommodate six disposable single-use assay cassettes · methods for manipulating sample and reagent movement within the cassette · heaters for lysis, elution and nucleic acid amplification · 6 optical channels · fluorometer for real-time PCR fluorescence detection and melt analysis · methods for thermal and optical calibration · software for running and analyzing IVD assays 2. Principles of Operation: a. Device Features Controlled by Software: 2 The ARIES® SYSTEM instrument uses the ARIES® Software 1.0 software and the ARIES® Assay Protocol file for data acquisition, analysis, and reporting. The ARIES® instrument software is installed on the embedded PC and controls the two modules housed in the instrument. The ARIES® Instrument is a Real Time PCR Instrument. The ARIES® instrument software provides the interface between the ARIES® Software 1.0 and the ARIES® system hardware. The ARIES® system software communicates to the instrument software to manage operations of the system, including manipulation of sample and reagent movement within the cassette, control of heaters for lysis, elution and nucleic acid amplification, controlling the fluorimeter for real-time PCR bulk fluorescence detection and melt analysis, controlling thermal and optical calibration and data analysis for IVD assays run on the system. The ARIES® Software 1.0 software is installed in an embedded computer and provides the graphical user interface (GUI) application that is intended to be the end- user interface to the ARIES® instrument. The ARIES® Software 1.0 software is responsible for providing the environment in which an end-user runs and reports assays, administers, maintains, and sets default settings for the system. The ARIES® Assay Protocol Software is a framework that allows running assays and generating reports on an ARIES® instrument. The ARIES® Assay Protocol Software is contained within an assay protocol template. This template is a read-only type of assay protocol file that contains a specific script, data reduction, assay editor tool, and reports, and default assay parameters and blank call logic. The ARIES® Assay Protocol file that is generated contains assay logic (rules that specify clinical outcomes), data reduction runtime files (DLL), and assay configuration parameters (script parameters that control the instrument for running a sample in a cassette and data reduction algorithm parameters). b. Operational Environment (Off-the-Shelf Software): The ARIES® Software 1.0 software uses some commercial off-the-shelf software components. The sponsor provided detailed documentation for the OTS used, including validation, for both the ARIES® Software 1.0 software and the ARIES® Assay Protocol Software. For the ARIES® Assay Protocol Software used by Luminex, the recommended configuration for each computer is: • Windows 7 Professional SP1 (US English, 32 bit or 64 bit) • 2.8 GHz Intel Dual Core (or higher) • 4 Gb RAM (or higher) • 160 GB hard drive (or higher) The programming language used to develop the ARIES® Software 1.0 software was 3 Microsoft Visual C#. Instrument control software was written in a combination and C# and C++. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ___x_____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No ___x_____ 4. Specimen Identification: A barcode reader may be used for entry of sample IDs, or they may be entered manually. 5. Specimen Sampling and Handling: Samples are manually prepared according to assay manufacturer’s suggestions and are transferred to an assay specific cassette for analysis. 6. Calibration: Calibration is performed by Luminex service personnel using ARIES® System Verification Cassettes. 7. Quality Control: Each ARIES® assay cassette includes a Sample Process Control (SPC). The SPC has a known melting temperature (Tm) range and cycle threshold (Ct) range. Each time an assay is run, the system measures the temperature and fluorescence intensity of the SPC control to ensure the thermal and optical subsystems have remained in calibration. 8. Software: FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types: Yes_____x___ or No________ 4 F. Regulatory Information: 1. Regulation section: 21 CFR 862.2570 Instrumentation for clinical multiplex test systems 2. Classification: Class II (special controls) 3 Product code: OOI – Real-time nucleic acid amplification 4. Panel: Chemistry (75) G. Intended Use: 1. Indication(s) for Use: The Luminex ARIES® System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. 2. Special Conditions for Use Statement(s): For prescription use only. H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: BD Diagnostics (Becton, Dickinson and Company), BD MAX System K111860 2. Comparison with Predicate Device: Similarities Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) Intended Use The Luminex ARIES® System is an in vitro Same 5 Similarities Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence- based PCR. Sample Preparation Method Automated nucleic acid lysis and extraction by the ARIES® system Same Assay Format Amplification: Real Time PCR Detection: Fluorgenic Same Interpretation of Test Results Automated (Diagnostic software of Luminex ARIES® System) Same Differences Item New Device: Luminex ARIES® System Predicate Device: BD Max System (k111860) Fluidics Self-contained Manual sample preparation Assay Cartridge · Cartridge is closed to the environment · Single Use · Reagent strips are open to the environment · Can be used twice Fluorescence Channels Six (6) channels Five (5) channels Software Software resides on the ARIES® System Software resides on an all- in-one computer I. Special Control/Guidance Document Referenced (if applicable): · IEC60825 – Safety of laser products, 2nd edition, 2007 · IEC62304, - Medical Device Software – Software Life Cycle Processes, 2006 · ISO 14971 – Medical Devices – Applications of Risk Management, 2007 · ISO15223-1 – Medical Devices – Symbols to be used with Medical Device Labels, Labelling, and Information to be Supplied, 2007 6 J. Performance Characteristics: 1. Analytical Performance: Performance for the ARIES® System was established in the clearance of the assay, the ARIES® HSV1&2 Assay (k151906). a. Accuracy: See k151906 b. Precision/Reproducibility: See k151906 c. Linearity: See k151906 d. Carryover: See k151906 e. Interfering Substances: See k151906 2. Other Supportive Instrument Performance Data Not Covered Above: Not applicable K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Classification: