The GenePOC"M Strep A assay, performed on the revogene"14 instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC™ Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.

Device Description

The GenePOC™ Strep A assay is a single-use test for qualitative detection of Streptococcus pyogenes (group A Streptococcus - GAS) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOCTM Strep A assay kit is comprised of the disposable Strep A microfluidic cartridge (PIE), Sample Buffer Tube (SBT), and Disposable Transfer Tool (DTT). These components are used to suspend the sample, extract, amplify, and detect Streptococcus pyogenes (S. pyogenes) nucleic acid.

A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure. The GenePOC™ Strep A assay is designed to be used on the revogene™. The revogene™ is an instrument that automates sample homogenization, sample dilution, cell lysis, DNA amplification and detection of the amplified PCR products.

Each GenePOC™ Strep A assay kit provides components for twenty-four (24) tests. User intervention is required for sample preparation, transferring throat swab specimen into the SBT, using the DTT to transfer the sample into the PIE, and loading the PIE into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps.

During the run and at run completion, the results are computed by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. An Early Positive Result Outcome (E-PRO) feature provides positive result if the signal from the target DNA reaches a predetermined threshold before the full PCR cycles have been completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

AI/ML Overview

The provided text describes the acceptance criteria and the study proving the GenePOC™ Strep A device meets these criteria. Since the document is a 510(k) summary for an in vitro diagnostic (IVD) assay, the acceptance criteria are generally related to analytical performance (e.g., precision, detection limit, inclusivity, specificity, interference) and clinical performance (sensitivity and specificity compared to a reference method). The study design is focused on demonstrating the reliability and accuracy of the diagnostic test in detecting Streptococcus pyogenes.

Here's the breakdown of the information requested based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD such as this, the acceptance criteria are typically implicit in the "Performance Characteristics" section, where the manufacturer demonstrates that the device performs reliably and accurately for its intended use. There are no explicit pass/fail acceptance values stated for each measured characteristic, but the reported performance values are the data presented to demonstrate adequacy.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision/Reproducibility		Overall Qualitative Agreement
Within-Laboratory Precision	High agreement for negative, low positive, and moderate positive samples	Negative: 97.5% (95% CI: [91.3%-99.7%]) (78/80 detected negative)Low Positive: 100% (95% CI: [96.3%-100%]) (80/80 detected positive)Moderate Positive: 100% (95% CI: [96.3%-100%]) (80/80 detected positive)
Between-Laboratory Reproducibility	High agreement across multiple sites for low positive, moderate positive, and negative samples	Low Positive: 100% (95% CI: [96.7%-100%]) (90/90 detected positive)Moderate Positive: 100% (95% CI: [96.7%-100%]) (90/90 detected positive)Negative: 100% (95% CI: [97.5%-100%]) (120/120 detected negative)
Between-Lot Reproducibility	High agreement across multiple reagent lots for low positive, moderate positive, and negative samples	Low Positive: 97.8% (95% CI: [92.2-99.7%]) (88/90 detected positive)Moderate Positive: 100% (95% CI: [96.7-100%]) (90/90 detected positive)Negative: 100% (95% CI: [97.5-100%]) (120/120 detected negative)
Limit of Detection (LoD)	To establish the lowest detectable concentration of S. pyogenes	Ranges from 333 to 1,333 CFU/mL of Sample Buffer (SB) depending on the strain. Confirmed with various swab types.
Analytical Reactivity/Inclusivity	To detect a broad range of clinically relevant Streptococcus pyogenes strains with high positivity	8 out of 9 strains detected with 100% positivity at 999 CFU/mL SB. One strain (ATCC® 49399™) detected with 100% positivity at 1667 CFU/mL SB. (9/9 replicates for each)
Analytical Specificity/Cross-Reactivity	No cross-reactivity with common throat/mouth microorganisms, phylogenetically related species, or human gDNA	No cross-reactivity observed among 50 non-specific analytes tested (concentrations up to ≥10^6 CFU/mL or cp/mL). Bioinformatic analysis also showed no significant homology with primers/probe.
Carry-over and Cross-Contamination	No false positive results due to carry-over or cross-contamination	No false positive results detected (n=80 in cross-contamination, n=80 in carry-over).
Assay Interference	Minimal to no interference from endogenous/exogenous substances or other microorganisms at relevant concentrations	Some substances (Analgesic/Antipyretic, NSAID, Bronchodilator, Whole Blood, Mucin) showed inhibitory effect at high concentrations (4.3% w/v or v/v) but no reportable interference at lower, clinically relevant concentrations (0.1-0.4% w/v or v/v). A combinatory effect of specific Streptococcus species or S. dysgalactiae was noted as potentially inhibitory.
Clinical Performance	High sensitivity and specificity for direct detection of S. pyogenes in throat swab specimens compared to the reference method (culture).	Sensitivity: 98.1% (151/154), 95% CI: [94.4% - 99.3%]Specificity: 94.7% (426/450), 95% CI: [92.2% - 96.4%]

2. Sample Sizes Used for the Test Set and Data Provenance

Clinical Performance Test Set (Clinical Studies):
- Sample Size: 604 fully compliant prospective specimens.
- Data Provenance:
  - Country of Origin: Geographically diverse clinical trial sites; two (2) in Canada and six (6) in the United States.
  - Retrospective or Prospective: Prospective multicenter trial. Throat swab specimens were collected from patients with signs and symptoms of pharyngitis.
Analytical Performance Test Sets (Examples):
- Within-Laboratory Precision: 240 samples (80 low positive, 80 moderate positive, 80 negative samples) tested over 20 days.
- Between-Laboratory Reproducibility: 300 samples (90 low positive, 90 moderate positive, 120 negative samples) tested across 3 sites over 5 days.
- Between-Lot Reproducibility: 300 samples (90 low positive, 90 moderate positive, 120 negative samples) tested across 3 reagent lots over 15 days.
- Limit of Detection: 24 replicates per concentration per strain (3 strains) with 3 kit lots; confirmation with 20 replicates per strain.
- Analytical Reactivity/Inclusivity: 9 replicates per strain (12 strains total).
- Analytical Specificity: 50 analytes, concentrations tested for each.
- Carry-over and Cross-Contamination: 80 samples for cross-contamination, 80 samples for carry-over.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Clinical Performance Test Set: The ground truth for the clinical study was established by a "Reference Method" which is explicitly stated as culture. The text does not mention the number or qualifications of human experts (e.g., microbiologists, lab technicians) involved in performing or interpreting the reference culture method, as culture is considered the gold standard and its results are objective.
- For discrepancies in the clinical study, an "alternative PCR with bi-directional sequencing" was performed on the discordant samples. This suggests a secondary method for adjudication rather than expert consensus on the primary ground truth.

4. Adjudication Method for the Test Set

Clinical Performance Test Set:
- The primary ground truth was established by the Reference Method (culture).
- For discordant results between the GenePOC™ Strep A assay and the culture, an alternative PCR with bi-directional sequencing was used for further investigation. This is a form of discrepancy resolution or adjudication for the clinical performance data. The results of this alternative PCR are footnoted in the clinical performance table (e.g., "17 of 24 were Strep A Positive" for samples positive by GenePOC but negative by culture).
- The text does not indicate a system like 2+1 or 3+1 involving human experts directly adjudicating case outcomes for the primary study endpoint; rather, it uses a technical discrepancy resolution method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an automated, qualitative in vitro diagnostic test for direct detection of nucleic acids. It does not involve human "readers" or image interpretation tasks where AI assistance would directly improve human reader performance. The device provides a direct positive/negative/indeterminate result.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, implicitly. The device, the GenePOC™ Strep A assay on the revogene™ instrument, is described as an "automated, qualitative in vitro diagnostic test." Once the sample is loaded, "No operator intervention is necessary once the PIE is loaded onto the revogene™." The results are "computed by the revogene™ from measured fluorescent signals and embedded calculation algorithms."
The clinical performance study directly evaluates this standalone performance (assay results vs. culture ground truth). The human element is in sample preparation and loading, but the detection and result interpretation are automated by the device.

7. The Type of Ground Truth Used

Clinical Performance Test Set: Culture (for Streptococcus pyogenes). This is the traditional "gold standard" for bacterial identification in clinical microbiology.
Analytical Performance Test Sets: Defined scientific standards, such as known concentrations of specific bacterial strains (CFU/mL), absence of target (negative matrix), and specific interfering substances, or bioinformatic analysis for sequence specificity.

8. The Sample Size for the Training Set

This document is a 510(k) summary for an IVD test, not a machine learning or AI algorithm summary. The "device" here refers to a diagnostic assay kit used on an automated instrument.
The assay's "embedded calculation algorithms" determine the results based on fluorescent signals and pre-set thresholds/cut-offs for RNA/DNA detection. There is no mention of a "training set" in the context of machine learning model training. The cut-offs were determined by testing n=509 native and contrived samples, which could be considered an "assay development" or "validation" dataset rather than a "training set" for a continually learning algorithm.

9. How the Ground Truth for the Training Set Was Established

As noted above, there isn't a traditional "training set" in the machine learning sense. The assay cut-offs were established using a mix of "native (throat swab specimens) and contrived samples" (n=509). The ground truth for these would logically be established by the same reliable reference method (culture) or by known spiked concentrations for contrived samples.

Summary

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5.0 510(K) SUMMARY

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510(K) SUMMARY

A. GENERAL INFORMATION

Submission Date:	February 21st, 2019
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Submitter Information:

Submitted By:	GenePOC Inc.
	360 rue Franquet
	Québec (Québec) G1P 4N3
Contact Person:
Contact Person:	Dany LeblancVP Quality Assurance and Regulatory AffairsGenePOC Inc.Telephone: +1 418 650-3535Email: dany.leblanc@genepoc.ca

B. PURPOSE FOR SUBMISSION

To obtain a substantial equivalence determination for the GenePOC™ Strep A

C. MEASURAND

Conserved regions of the Streptococcus pyogenes bacterial genome

D. TYPE OF TEST

Real-time polymerase chain reaction (PCR)

E. APPLICANT

GenePOC Inc.

F. PROPRIETARY AND ESTABLISHED NAMES

GenePOC™ Strep A

G. REGULATORY INFORMATION

Trade Name:	GenePOC™TM Strep A
Classification:	Class II
Regulation:	21 CFR 866.2680
Regulation Name:	Streptococcus spp. nucleic acid-based assay
Product Code:	PGX and OOI
Panel:	83 - Microbiology

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H. INTENDED USE

1. Intended Use and Indications for Use:
  The GenePOC"M Strep A assay, performed on the revogene"14 instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC™ Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.
1. Special conditions for use statement(s): Prescription Use Only
1. Special instrument requirements: revogene™M

I. INDICATIONS FOR USE

Same as Intended Use.

J. DEVICE DESCRIPTION

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feature provides positive result if the signal from the target DNA reaches a predetermined threshold before the full PCR cycles have been completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

K. SUBSTANTIAL EQUIVALENCE INFORMATION

1. Predicate Device Name: Xpert Xpress Strep A
1. Predicate 510(k) Number: K172126
1. Comparison with Predicate:

Item	GenePOCTM Strep A	Xpert Xpress Strep A(Predicate Device)
K Number	K183366	K172126
SIMILARITIES
Regulation	21 CFR 866.2680	Same
Classification	Class II	Class II
Intended Use	The GenePOC™ Strep A assay,performed on the revogeneTMinstrument, is an automated,qualitative in vitro diagnostic test thatutilizes real-time polymerase chainreaction (PCR) for the direct detectionof Streptococcus pyogenes (Group Aß-hemolytic Streptococcus) nucleicacids from throat swab specimensobtained from patients with signs andsymptoms of pharyngitis. TheGenePOC™ Strep A assay is intendedfor use as an aid in the diagnosis ofGroup A Streptococcus infection.	The Xpert Xpress Strep A Assay,performed on the GeneXpertInstrument Systems, is a rapid,qualitative in vitro diagnostic test forthe detection of Streptococcuspyogenes (Group A ß-hemolyticStreptococcus, Strep A) in throat swabspecimens from patients with signsand symptoms of pharyngitis.The Xpert Xpress Strep A Assayutilizes an automated real-timepolymerase chain reaction (PCR) todetect Streptococcus pyogenes DNA.
DNA Target	Group A Streptococcus	Same
DNA Extraction	Automated by instrument	Same
Assay Format	Amplification: Real-time PCRDetection: Fluorogenic target-specifichybridization	Same
Detection Probes	TaqMan® Probe	Same
Automatic Assay	Yes-result interpretation	Same
Internal ProcessControl	To verify presence of potentialinhibitory substances as well as anymicrofluidic, instrument or reagentfailures.	Same
External Control	Materials available commercially butnot required to run the test	Same
Result Format	Qualitative	Same
Sample Preparation	Automated by revogene™	Automated

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Item	GenePOC™ Strep A	Xpert Xpress Strep A(Predicate Device)
Interpretation of TestResults	Automated (Diagnostic software ofthe revogene™)	Automated
Specimen Type	Throat swab (rayon or polyester) inLiquid Stuart or Liquid AmiesTransport Medium	Throat swab in Liquid AmiesTransport Medium
DIFFERENCES
Instrument System	revogene™	GeneXpert Dx, GeneXpert Infinity-48s or GeneXpert Infinity-80instrument systems

L. STANDARDS/GUIDANCE DOCUMENTS REFERENCED

CLSI Guideline EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; . Approved Guideline.
CLSI Guideline EP05-A3, Evaluation of Precision of Quantitative Measurement ● Procedures; Approved Guideline.
CLSI Guideline EP17-A2, Evaluation of Detection Capability for Clinical Laboratory . Measurement Procedures; Approved Guideline.

M. TEST PRINICIPLE

The revogene™ automates and integrates nucleic acid extraction and amplification, and detection of the target sequence in complex samples using real-time PCR. A throat swab specimen is collected using a rayon tipped swab, the specimen is transferred into the SBT containing 1.5 mL of sample buffer, and the swab stem is broken. After a 15-second vortex step at maximal speed, the inoculated sample buffer is transferred into the GenePOC™ Strep A PIE using the DTT. The loaded GenePOC™ Strep A PIE is placed into the revogene™ for further sample processing. No operator intervention is necessary once the PIE is loaded onto the revogene™.

Each GenePOC™ Strep A PIE is a completely integrated and self-contained device. Each sample is sequentially transferred by centrifugation from one microfluidic chamber to the next and all reagents specific for the PCR reaction are incorporated and dried within the PCR wells. The stepwise process includes sample homogenization, lysis of cells, sample dilution, and DNA extraction followed by the subsequent real-time PCR steps within one PCR well in the cartridge. An internal PrC is contained in the homogenization chamber and is therefore present in every test to verify critical steps of the analytical process (including sample lysis, dilution and nucleic acid amplification and detection) and for the presence of potential inhibitory substances as well as system or reagent failures. The amplified products are detected in realtime using target-specific TaqMan® chemistry-based probes. The results are computed by the system from measured fluorescent signals and embedded calculation algorithms. An Early Positive Result Outcome (E-PRO) feature provides positive result if the signal from the target DNA reaches a predetermined threshold before the full PCR cycles have been completed. Results may be viewed, printed, transferred, and/or stored by the user.

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N. PERFORMANCE CHARACTERISTICS

1. Analytical Performance

Precision/Reproducibility a.

Within-Laboratory Precision:

In accordance with the CLSI Guidelines EP05-A3, the Within-Laboratory Precision of the assay was performed at one (1) site and tested specimens with one (1) GenePOCTM Strep A reagent lot over twenty (20) days (consecutives or not) by two (2) operators, at the rate of one (1) run per operator per day using one (1) revogene™ instrument. Two (2) replicates of each sample type were included in a single run and tested daily by each operator for a total of eighty (80) replicates after twenty (20) days.

SampleComposition	Strain	Load Tested(LoD)	Load Tested(CFU/mL of SB)
Low Positive	S. pyogenesATCC 12344	1.95x LoD	650
Moderate Positive	S. pyogenesATCC 19615	3x LoD	3000
Negative	N/A	N/A	N/A

Description of the Precision/Reproducibility Panels

Overall, two-hundred and forty (240) samples (80 low positive, 80 moderate positive and 80 negative samples) were tested in presence of S. pyogenes-negative throat matrix during this within-laboratory precision study with the GenePOC™ Strep A assay. The overall agreement of assay results is 97.5% (95% CI: [91.3%-99.7%]) for negative samples, 100% (95% CI: [96.3%-100%]) for low positive samples and 100% (95% CI: [96.3%-100%]) for moderate positive samples.

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Sample Type	Strain	Positive Results/Total	Agreement (%)195% CIJ
Low Positive	S. pyogenesATCC 12344	80/80	100[96.3%-100%]
Moderate Positive	S. pyogenesATCC 19615	80/80	100[96.3%-100%]
Sample Type	Strain	Negative Results/Total	Agreement (%)195% CII
Negative	N/A	78/80	97.5[91.3%-99.7%]

Within-Laboratory Precision Qualitative Analysis and Overall Agreement

Results for the Ct Values Analysis of Within-Laboratory Precision Study

S. pyogenes
SampleType	Strain	MeanCt( S.pyo )	N	Between-Days		Between-Runs		Repeatability		Overall
				SD	%CV	SD	%CV	SD	%CV	SD	%CV
LowPositive	S. pyogenesATCC12344	37.65	80	0.00	0.00	0.00	0.00	1.67	4.44	1.67	4.44
ModeratePositive	S. pyogenesATCC19615	36.52	80	0.40	1.09	0.43	1.19	1.66	4.54	1.76	4.82
					PrC
SampleType	Strain	MeanCt( PrC )	N	Between-Days		Between-Runs		Repeatability		Overall
Negative	N/A	28.56	78	0.08	0.27	0.00	0.00	0.84	2.95	0.85	2.96

The overall %CV of PrC for all 78 negative samples obtained for the Within-Laboratory Precision is 2.96%.

Between-Laboratory Reproducibility:

The Between-Laboratory Reproducibility study was performed with one (1) GenePOCTM Strep A assay reagent lot (Kit Lot #1) on five (5) days (consecutive or not) by two (2) operators, at three (3) sites. Two (2) runs were performed by each operator on each day. Overall, 300 samples (90 low positive, 90 moderate positive and 120 negative samples) were tested in presence of S. pyogenes-negative throat matrix during this Between-Laboratory Reproducibility study with the GenePOC™ Strep A assay.

The overall agreement of assay results for the Between-Laboratory Reproducibility study was 100% (95% CI: [96.7%-100%]) for Low Positive (LP) samples, 100% (95%

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CI: [96.7%-100%]) for Moderate Positive (MP) samples and 100% (95% CI: [97.5-100%]) for True Negative (TN) samples.

Between-Laboratory Reproducibility Qualitative Analysis and Overall Agreement

Panel Member	Strain	Site 1PositiveResults/Total(% Agreement)	Site 2PositiveResults/Total(% Agreement)	Site 3PositiveResults/Total(% Agreement)	PositiveResults/Total	OverallAgreement(%)
		POS/Total				[95% CI]
Low Positive(1.95x LoD)	S. pyogenesATCC12344	30/30(100%)	30/30(100%)	30/30(100%)	90/90	100.0%[96.7-100.0]
Moderate Positive(3x LoD)	S. pyogenesATCC19615	30/30(100%)	30/30(100%)	30/30(100%)	90/90	100.0%[96.7-100.0]

Between-Laboratory Reproducibility Qualitative Analysis and Overall Agreement for Negative Panel Members

PanelMember	Strain	Site 1Negative /Total(% Agreement)	Site 2Negative /Total(% Agreement)	Site 3Negative/Total(% Agreement)	NegativeResults/Total	Overall Agreement(%)
			NEG/Total			[95% CI]
Negative	N/A	40/40(100%)	40/40(100%)	40/40(100%)	120/120	100.0%[97.5-100.0]

Results for the Ct Values Analysis of Between-Laboratory Reproducibility Study

S. pyogenes
SampleType	Strain	MeanCt( S.pyo )	N	Between-Laboratory		Between-Operators		Between-Days		Repeatability(ResidualError)		Overall
				SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
LowPositive	S. pyogenesATCC12344	36.97	90	0.27	0.72	0.72	1.96	0.61	1.65	1.61	4.35	1.88	5.10
ModeratePositive	S. pyogenesATCC19615	34.98	90	0.26	0.73	0.00	0.00	0.00	0.00	0.71	2.02	0.75	2.15
PrC
SampleType	Strain	MeanCt(PrC)	N	Between-Laboratory		Between-Operators		Between-Days		Repeatability(ResidualError)		Overall
				SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
Negative	N/A	28.52	120	0.21	0.73	0.00	0.00	0.00	0.00	0.66	2.31	0.69	2.42

Between-Lot Reproducibility:

The Between-Lot Reproducibility study was assessed only at one (1) site where the same experiment was repeated with two (2) additional reagent lots (Kit Lot #2 and Kit Lot #3) for a total of fifteen (15) days of testing (five days per reagent lot). Overall,

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300 samples (90 low positive. 90 moderate positive and 120 negative samples) were tested in presence of S. pyogenes-negative throat matrix during this Between-Lot Reproducibility study with the GenePOC™ Strep A assay.

The overall agreement of assay results for the Between-Lot Reproducibility study was 97.8% (95% CI: [92.2-99.7%]) for Low Positive (LP) samples, 100% (95% CI: [96.7-100% |) for Moderate Positive (MP) samples and 100% (95% CI: [97.5-100% ]) for True Negative (TN) samples.

Between-Lot Reproducibility Qualitative Analysis and Overall Agreement

PanelMember	Strain	Lot #1PositiveResults/Total(% Agreement)	Lot #2PositiveResults/Total(% Agreement)POS/Total¹	Lot #3PositiveResults/Total(% Agreement)	PositiveResults/Total	Agreement(%)
						[95% CI]
Low Positive(1.95x LoD)	S. pyogenesATCC12344	30/30(100%)	29/30(96.6%)	29/30(96.7%)	88/90	97.8%[92.2-99.7]
ModeratePositive(3x LoD)	S. pyogenesATCC19615	30/30(100%)	30/30(100%)	30/30(100%)	90/90	100.0%[96.7-100.0]

Between-Lot Reproducibility Qualitative Analysis and Overall Agreement for Negative Panel Members

PanelMember	Strain	Lot #1Negative/ TotalAgreement)	Lot #2Negative/ TotalAgreement)	Lot #3Negative/ TotalAgreement)	Negative/Total	Agreement(%)
			NEG/Total			[95% CI]
Negative	N/A	40/40(100%)	40/40(100%)	40/40(100%)	120/120	100.0%[97.5-100.0]

Results for the Ct Values Analysis of Between-Lot Reproducibility Study

S. pyogenes
SampleType	Strain	MeanCt(Spyo)	N	Between-Lot		Between-Operators		Between-Days		Repeatability(ResidualError)		Overall
				SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
LowPositive	S. pyogenesATCC12344	37.85	88	0.00	0.00	0.92	2.42	1.17	3.08	1.76	4.65	2.30	6.08
ModeratePositive	S. pyogenesATCC19615	35.49	90	0.00	0.00	0.43	1.21	0.00	0.00	1.55	4.37	1.61	4.53

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The maximal overall %CV of PrC Ct values for Negative samples obtained for both Between-Laboratory and Between-Lot Reproducibility studies was 2.61% (%CV values).

b. Linearity/Assay Reportable Range

Not applicable.

c. Traceability, Stability, Expected Values (controls, calibrators, or methods)

Internal process control (PrC):

Each PIE contains a PrC that controls for amplification inhibition, assay reagents, and sample processing effectiveness

External Controls:

Two (2) External Controls that must be prepared by the end user. These are recommended but not required to allow the user to select the most appropriate for their laboratory quality control program.

GenePOC recommends using a 0.5 ± 0.05 MacFarland (McF) suspension of a S. pyogenes commercially available strain (e.g., ATCC® 12344™) diluted 1/100 in saline as a Positive External Control and a 0.5 ± 0.05 McF suspension of a Streptococcus salivarius commercially available strain (e.g., ATCC® 13419™) as a Negative External Control.

Sample Stability in the PIE:

The GenePOCTM Strep A assay PIE (microfluidic cartridge) stability study was validated using positive samples comprised of the S. pyogenes (GAS) strain ATCC® 12344™ and negative samples in presence of S. pyogenes-negative throat matrix. The study was conducted using three (3) GenePOC™ Strep A kit lots, three (3) replicates of S. pyogenes and negative samples (one replicate per kit lot), and five (5) revogene™ instruments.

The results of the study support the recommended maximum interval of one (1) hour from the opening of the PIE pouch and sample addition into the GenePOC™ Strep A assay PIE to the processing on the revogene™ instrument.

Nested Specimen Stability:

This study evaluated the stability of the throat swab specimens collected with rayon swabs with Liquid Stuart transport media, and the inoculated SBT used in the GenePOC™ Strep A assay. The time periods tested in this study established specimen stability between i) throat swab specimen collection and SBT inoculation and ii) SBT inoculation and loading of the GenePOCTM Strep A PIE prior to initiation of the revogene™ run.

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The nested stability was determined by testing positive samples comprised of the S. pyogenes (GAS) strain ATCC® 12344™, and negative samples in presence of S. pyogenes-negative throat matrix. The study included three (3) lots GenePOC™ Strep A assay kits. For each sample type (positive or negative), and for each time point, a total of twelve (12) swabs were inoculated (4 swabs for each matrix pool, i.e., 4 replicates per kit lot).

Study results support throat swab specimen storage at 25±2°C up to two (2) days or 2-8°C for up to seven (7) days. SBT inoculated with throat swab specimens may be stored up to three (3) days at 25-2°C or 2-8°C for up to seven (7) days prior testing with the GenePOC™ Strep A assay.

Nested Specimen Stability - Various Swabs:

This study confirms the cumulative stability (nested stability) of throat swabs specimens when collected and conserved with Rayon Liquid Amies, Polyester Liquid Stuart, Polyester Liquid Amies and the inoculated SBT used with the GenePOCTM Strep A assay at defined temperature of 25 ± 2°C and 2-8°C.

The nested confirmation study was executed by testing S. pyogenes (GAS) strain ATCC® 12344™ at 3x LoD (999 CFU/ml) of Sample Buffer (SB) and negative samples in presence of S. pyogenes-negative throat matrix. The study included three (3) to four (4) lots GenePOCTM Strep A assay kits for each type of swab. For each sample type (positive or negative), and for each time point, a total of twelve (12) swabs were inoculated (four (4) swabs for each matrix pool, i.e., four (4) replicates per kit lot).

Study results support throat swab specimen nested stability for GenePOC™ Strep A assay at 25±2℃ up to two (2) days or 2-8℃ for up to seven (7) days; SBT inoculated with throat swab specimens may be stored up to three (3) days at 25±2°C or 2-8°C for up to seven (7) days prior testing with the GenePOC™ Strep A assay, as confirmed with the rayon swab in Liquid Amies transport media and Polyester swab in Liquid Stuart and Liquid Amies transport media.

Reagent Stability

The shelf life of the GenePOC™ Strep A assay reagents was evaluated in a real time stability study performed on three (3) lots of reagents that were stored under different conditions. GenePOC claims a shelf life of 63 days (2 months) at 2-8°C and 25 ± 3°C with 60 ± 10% RH. GenePOC will claim reagent stability of two (2) months in the product labeling at the time of 510(k) submission.

d. Detection Limit

The Limit of Detection (LoD) was established and confirmed in two separate studies. The LoD of the GenePOC™ Strep A assay was established using throat swab specimen matrix collected from rayon swab in Liquid Stuart transport media (previously tested negative for S. pyogenes) spiked with various concentrations of S. pyogenes bacterial suspensions. Three (3) strains of S. pyogenes (ATCC® 12344™, ATCC® 19615™, and

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ATCC® 700942™) were tested in twenty-four (24) replicates per concentration with three (3) GenePOCTM Strep A kit lots.

In accordance with the CLSI Guideline EP17-A2, the confirmation of the LoD was conducted during three (3) days using one (1) GenePOC™ Strep A kit lot and one (1) revogene™ instrument per strain. Two (2) different preparations of each S. pyogenes strain (ATCC® 19615, ATCC® 12344, and ATCC® 700942) were used in the study. A total of twenty (20) replicates per strain in presence of S. pyogenes-negative throat matrix was tested. The LoD of the GenePOC™ Strep A assay ranges from 333 to 1,333 CFU/mL of SB.

The LoD for each S. pyogenes strain was also confirmed with the rayon swab in Liquid Amies transport media and polyester swab in Liquid Stuart and Liquid Amies transport media.

Analytical Reactivity/Inclusivity

The analytical reactivity (inclusivity) of the GenePOC™ Strep A assay was determined for twelve (12) strains of Streptococcus pyogenes GAS (Lancefield group A) representing six (6) different emm sequence types from various geographic origins. Nine (9) strains were tested in presence of S. pyogenes-negative throat matrix at a load of 999 CFU/mL of SB (3xLoD). Three (3) lots of GenePOC™ Strep A kits were used for sample testing (n=3 strains/kit lot). Eight (8) S. pyogenes strains were detected with 100% positivity (in 9/9 replicates) by the GenePOC™ Strep A assay at a load of 999 CFU/mL of SB. The S. pyogenes ATCC® 49399™ strain was detected with 100% positivity at a load of 1667 CFU/mL of SB.

Species	StrainIdentification	Lancefield Group	Emm-type
Streptococcuspyogenes	ATCC 12384	A	3
	ATCC 49399	A	N/A
	CCUG 33409	A	N/A
	CCUG 39158	A	N/A
	CCUG 53553	A	N/A
	ATCC 700952	A	92
	ATCC 700294	A	1
	ATCC 12357	A	18
	CCUG 65322	A	N/A
	ATCC 196151	A	80
	ATCC 123441	A	1
	ATCC 7009421	A	82

S. pyogenes Strains utilized in the Analytical Inclusivity Study

1 Strains used for the LoD determination and therefore not retested

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Analytical Specificity

A total of fifty (50) various analytes found in clinical throat swab specimens (different from S. pyogenes) were selected. These included:

Commensal and pathogenic microorganisms (bacteria, yeast and viruses) from the . throat or mouth:
Species phylogenetically related to S. pyogenes; .
. Human gDNA.

Forty-two (42) bacteria and one (1) yeast were tested at a concentration of ≥10° CFU/mL of SB in presence of S. pyogenes-negative throat matrix. Six (6) viral nucleic acid preparations and human genomic DNA were tested at a concentration of ≥10° cp/mL of SB in presence of S. pyogenes-negative throat matrix. No cross-reactivity was observed among the fifty (50) non-specific analytes tested.

Cross-Reactants Tested in the Analytical Specificity Study

Name	Identification	Name	Identification
Bacteria and Yeasts
Acinetobacter lwoffii	ATCC 15309	Klebsiella pneumoniae	ATCC 27736
Arcanobacterium haemolyticum	ATCC BAA-1784	Lactococcus lactis	ATCC 19435
Bacillus cereus	ATCC 14579	Legionella jordanis	ATCC 33623
Bordetella pertussis	ATCC 9797	Legionella micdadei (Tatlockia micdadei)	CCUG 31229
Burkholderia cepacia	ATCC 25416	Legionella pneumophila	ATCC 33152
Corynebacterium diphtheriae	ATCC 13812	Moraxella catarrhalis	ATCC 25238
Enterococcus faecalis	ATCC 19433	Neisseria gonorrhoeae	ATCC 43069
Escherichia coli	ATCC 11775	Neisseria subflava	ATCC 49275
Fusobacterium necrophorum	ATCC 25286	Parvimonas micra	ATCC 33270
Haemophilus influenza	ATCC 9006	Pseudomonas aeruginosa	ATCC 35554
Serratia marcescens	ATCC 13880	Streptococcus dysgalactiae subsp. dysgalactiae	ATCC 9926
Staphylococcus aureus	ATCC 33592	Streptococcus dysgalactiae subsp. dysgalactiae	ATCC 43078
Staphylococcus epidermidis	ATCC 14990	Streptococcus gordonii	ATCC 10558
Stenotrophomonas maltophilia	ATCC 13637	Streptococcus intermedius	ATCC 27335
Streptococcus agalactiae	ATCC 12403	Streptococcus mitis	NCIMB 13770
Streptococcus anginosus	ATCC 33397	Streptococcus mutans	ATCC 25175
Streptococcus anginosus subsp. whileyi	CCUG 39159	Streptococcus oralis	ATCC 6249
Streptococcus bovis	ATCC 33317	Streptococcus pneumoniae	ATCC 49619
Streptococcus canis	ATCC 43496	Streptococcus salivarius	ATCC 13419
Streptococcus constellatus subsp. viborgensis	CCUG 62387	Streptococcus sanguinis	ATCC 10556
Streptococcus suis	CCUG 7984	Veillonella parvula	ATCC 10790
		Candida albicans	ATCC 10231
Viruses and Human DNA
Adenovirus Type 1	ATCC VR-1D	Influenza A/Aichi/2/68/H3N2	ATCC VR-1680D
Influenza B/Taiwan/2/62	ATCC VR-1735D	Parainfluenza virus 4b	ATCC VR-1377D
Rhinovirus Type 17	ATCC VR-1663D	Human DNA	N/A
Adenovirus type 11 (Slobitski)	ATCC VR-12D

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Bioinformatic Analysis

The in silico specificity of the GenePOC™ Strep A assay was validated through the analysis of the assay's primers and probe sequences selected for the specific detection of S. pyogenes and to demonstrate, in silico, the level of sequence conservation within the targeted region.

The in silico study suggests that no non-specific amplifications or detection will occur with the primers and probe of the GenePOC™ Strep A assay for the detection of the targeted S. pyogenes sequence. The primers and probes have been proven to be specific to their respective target following Basic Local Alignment Search Tool (BLAST) analysis. No other target than S. pyogenes was found to have significant level of homology with the S. pyogenes primers and probe. Therefore, there is no evidence of potential cross-reactivity for this target.

In addition, it was concluded that the S. pyogenes target primers and probe do not interact with the PrC sequence. Thus, there is no risk to produce false positive results. Further, the PrC primers did not demonstrate cross-reactivity with other organisms.

Carry-over and Cross-Contamination Studies

Carry-over (between-run) and cross-contamination (within-run) were evaluated by running two studies using two (2) revogene™ instruments, one (1) for the crosscontamination study and one (1) for the carry-over study.

For the carry-over study, a total of ten (10) runs were performed by two (2) operators with the GenePOCTM Strep A assay on one (1) revogene. Testing was performed with alternating "high positive" (106 CFU/mL of Sample Buffer) and negative samples in presence of S. pyogenes-negative throat matrix. For the cross-contamination study, a run of eight (8)replicates of high positive samples followed by a run of eight (8) replicates of negative samples were performed by two (2) operators, for a total of ten (10) runs on one revogene.

No false positive results were detected in the within-run cross-contamination study (n=80) or in the between-run carry-over study (n=80).

e. Assay Cut-off:

Thresholds and cut-offs for the GenePOC™ Strep A assay are embedded within the Assay Definition File that also encodes the instrument settings required to perform the test. Both the native (throat swab specimens) and contrived samples were used to set the thresholds of positivity and negativity of the GenePOC™ Strep A assay. The assay cutoff was determined by testing n=509 native and contrived samples.

f. Assay Interference

The potential for interference with the GenePOC™ Strep A assay was evaluated with endogenous and exogenous substances that may be present in throat swab specimens,

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as well as a representative panel of commensal or potentially pathogenic microorganisms.

Interference with Exogenous and Endogenous Substances:

Interference on the GenePOC™ Strep A assay was evaluated with nineteen (19) potentially interfering substances, which included three (3) endogenous substances and sixteen (16) exogenous substances, identified because they could be present in a throat specimen.

Two (2) strains of S. pyogenes (ATCC® 12344™ and ATCC® 19615™) were tested at a moderate load (3xLoD, 999 CFU/mL and 3000 CFU/mL of SB, respectively) in the presence of potentially interfering substances and S. pyogenes-negative throat matrix. Negative samples were also tested in the presence of potentially interfering substances to evaluate the impact on the Process Control (PrC). The potentially interfering substances were tested at the highest concentration that may be encountered in a throat swab specimen.

Results demonstrated that Analgesic / Antipyretic (Tyleno1®), Nonsteroidal antiinflammatory drug (Aspirin®, Advil®), Bronchodilator (Albuterol sulfate), Whole Blood and Mucin showed a potentially inhibitory effect on the detection of PrC or S. pvogenes when any of these substances was present in SBT at a concentration of 4.3% (w/v or v/v). These substances showed no reportable interference with the GenePOC Strep A assay when tested at 0.4% (w/v) for Tylenol®, Advil®, Albuterol sulfate and Mucin or at 0.1% (w/v) or 0.1% (v/v) for Aspirin® and Whole Blood, respectively.

Microbial Interference:

The microbial interference study for the GenePOC™ Strep A assay evaluated thirty (30) potentially interfering non-targeted microorganisms genetically close to the assay analytes, flora potentially found in the mouth/throat/respiratory tract and the most frequent throat and upper respiratory tract infection causative agents. Two (2) S. pyogenes strains, ATCC® 12344™ and ATCC® 19615™, were tested at 3xLoD (999 CFU/mL and 3000 CFU/mL of SB respectively) in triplicate in presence of potentially interfering non-targeted microorganisms and S. pyogenes-negative throat matrix. Negative samples were also tested in the presence of potentially interfering nontargeted microorganisms to evaluate the impact on the PrC. None of the thirty (30) organisms present at 10° CFU/mL of SB for bacteria and yeast and 105 copies/mL of SB for viruses interfered with detection of PrC or with S. pyogenes strain ATCC 19615.

A combinatory effect of Streptococcus mutans, Streptococcus oralis, Streptococcus salivarius and Moraxella catarrhalis, at ≥10° CFU/mL of SB or the presence of Streptococcus dysgalactiae subsp. dysgalactiae, at ≥10° CFU/mL of SB, may have an inhibitory effect on the detection of S. pyogenes ATCC® 12344™. These results are noted in the device labeling.

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2. Comparison Studies

a. Method Comparison with predicate device Not applicable.
b. Matrix Comparison Not applicable.
1. Clinical Studies

GenePOC conducted a prospective multicenter trial at eight (8) geographically diverse clinical trial sites (seven (7) collecting sites and one (1) reference center), two (2) in Canada and six (6) in United States. Throat swab specimens were collected from patients with signs and symptoms of pharyngitis. Samples were tested with both the Reference Method (culture) and the GenePOC™ Strep A. Out of seven hundred and sixty-seven (767) enrolled specimens, one hundred and sixty-three (163) specimens were excluded: three (3) failed to comply with the revogene testing procedures, thirteen (13) exceeded the delay in shipment, twenty-three (23) did not meet inclusion criteria, twenty-seven (27) did not have complete testing results, and ninety-seven (97) failed to comply with the reference culture protocol. Six hundred and four (604) fully compliant samples were tested with both the Reference Method and the GenePOC™ Strep A assay for the performance estimation study. A total of three (3) lots of the GenePOC™ Strep A assay kits were used for testing. Because the primary objective of the trial was to establish the performance of the system, the results were not used in the patient management for S. pyogenes infection. This was done according to hospital standard operating practices in place at each institution.

The GenePOC™ Strep A assay sensitivity and specificity on the six hundred and four (604) prospective specimens were 98.1% (151/154) and 94.7% (426/450) respectively.

All sites		Reference Method		Total
		Positive	Negative
GenePOC™Strep A test	Positive	151	24a	175
	Negative	3b	426	429
	Total	154	450	604
Sensitivity		98.1% (151/154)	[94.4% - 99.3%]
Specificity		94.7% (426/450)	[92.2% - 96.4%]
PPV		86.3% (151/175)	[80.4% - 90.6%]
NPV		99.3% (426/429)	[98.0% - 99.8%]
Prevalence		25.5% (154/604)	[22.2% - 29.1%]

Overall performance (all sites combined) with the GenePOC™ Strep A assay in comparison with the Reference Method

Numbers between brackets indicate Wilson Score 95% CI

2 Results from alternative PCR with bi-directional sequencing: 17 of 24 were Strep A Positive; 6 of 24 were Strep A Negative and 1 was inconclusive.

b Results from alternative PCR with bi-directional sequencing: 1 of 3 was Strep A Positive and 2 were inconclusive.

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1. Clinical Cut-off Not applicable.
1. Expected Values/Reference Range

GenePOC conducted a multi-site prospective investigational study at eight (8) geographically diverse clinical sites (seven (7) collection centers and one (1) reference center) at which testing for S. pyogenes was performed with culture and the GenePOCTM Strep A assay. Per the CLSI Guideline EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, GenePOC calculated the prevalence of S. pyogenes using the culture positive results from the Clinical Performance Study. The overall S. pyogenes prevalence rate as determined by reference method was 25.5% (154/604).

O. INSTRUMENT NAME

revogene™M

P. SYSTEM DESCRIPTIONS

1. Modes of Operation:
  Real-time polymerase chain reaction with fluorogenic detection of amplified DNA.
1. Software:
  FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes _X or No _________________________________________________________________________________________________________________________________________________________

1. Specimen Identification:
  Barcodes are used to identify patient specimens. The GenePOC™ Strep A assay's SBT and PIE are both pre-labeled with a unique barcode to identify both specimen and assay. The instrument has two barcode readers to identify reagents and patient specimens. It provides traceability of the sample ID to the PIE ID, SBT ID, and assay ID.

4. Specimen Sampling and Handling:

User intervention is required for discharging the patient sample into the SBT, transferring the sample into the microfluidic cartridge using the DTT and for loading the microfluidic cartridge into the revogene™. All further specimen handling is automated.

1. Calibration:
  The system is factory calibrated by the manufacturer. The calibration is verified annually. Upon the verification, maintenance is performed if required.
1. Ouality Control:
  A PrC is provided in each microfluidic cartridge of the GenePOC™™™ Strep A assay. The PrC is lysed, amplified, and detected along with each specimen tested and verifies the

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efficacy of the DNA extraction and PCR amplification processes. Commercially available strains (e.g., ATCC® 12344™ and ATCC® 13419™) can be used as a Positive and Negative External Controls, respectively.

Q. OTHER SUPPORTIVE INSTRUMENT PERFORMANCE CHARACTERISTICS DATA NOT COVERED IN THE "PERFORMANCE CHARACTERISTICS" SECTION

Not applicable.

R. PROPOSED LABELING

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

S. CONCLUSION

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

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Image /page/18/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 6, 2019

GenePOC Inc. Dany Leblanc VP QA/RA 360 rue Franquet Québec G1P 4N3 Ca

Re: K183366

Trade/Device Name: GenePOC Strep A Regulation Number: 21 CFR 866.2680 Regulation Name: Streptococcus spp nucleic acid-based assay Regulatory Class: Class II Product Code: PGX, OOI Dated: November 30, 2018 Received: December 6, 2018

Dear Dany Leblanc:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{19}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Uwe Scherf. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 866.2680

Streptococcus spp. nucleic acid-based assay.(a)
Identification. AStreptococcus spp. nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify variousStreptococcus spp. nucleic acids extracted directly from clinical specimens. The device detects specific nucleic acid sequences for organism identification. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.
(2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination.
(3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.
(4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.
(5) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols, as appropriate.
(6) The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(8) Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate.