The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasopharyngeal and nasal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

Device Description

The BD Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens. The processed specimen is added to the test device where influenza A or influenza B viral anti-influenza antibodies conjugated to detector particles on the A+B test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. Results are interpreted by the BD Veritor™ System Reader, a portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and applies specific algorithms to determine the presence or absence of any target analyte(s). A liquid crystal display (LCD) on the instrument communicates the results to the operator.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Clinical Performance - All Swabs)

Criterion (Implicit - based on study results presented)	Influenza A Reported Device Performance (PPA)	Influenza A Reported Device Performance (NPA)	Influenza B Reported Device Performance (PPA)	Influenza B Reported Device Performance (NPA)
Clinical PPA (United States)	78.7% (95% C.I. 71.6%, 84.4%)	N/A	74.3% (95% C.I. 65%, 81.8%)	N/A
Clinical NPA (United States)	N/A	97.8% (95% C.I. 95.7%, 98.9%)	N/A	99.5% (95% C.I. 98.3%, 99.9%)
Clinical PPA (Japan)	94.4% (95% C.I. 86.4%-97.8%)	N/A	91.4% (95% C.I. 82.5%-96%)	N/A
Clinical NPA (Japan)	N/A	96.7% (95% C.I. 92.4%-98.6%)	N/A	94.7% (95% C.I. 89.9%-97.3%)

Note: The document doesn't explicitly state numerical acceptance criteria thresholds for PPA and NPA; rather, it presents the results from the clinical study as evidence of performance. The implicit acceptance is that these performance characteristics are adequate for its intended use and compare favorably to the predicate device, which is not detailed in terms of its performance here.

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

Sample Size for Clinical Performance: A total of 736 prospective specimens (515 in the U.S. and 221 in Japan).
Data Provenance: Prospective, collected at five U.S. trial sites and eight Japan trial sites during the 2010-2011 respiratory season.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth was established by Polymerase Chain Reaction (PCR), which is a molecular assay, not an expert panel.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the context of human interpretation. The comparison is between the device's results and a reference PCR method. However, for discordant results (PCR positive, BD Veritor negative), a second swab specimen from the same patient (the reference method specimen) was tested with the BD Veritor assay to investigate the discrepancy. This isn't a traditional adjudication with human readers, but a re-testing mechanism.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated diagnostic test (an optical reader interprets the test strip), not an AI system designed to assist human readers. Thus, there is no "human readers improve with AI vs without AI assistance" effect size.

6. If a Standalone Study Was Done

Yes, a standalone study was performed. The clinical performance data (PPA, NPA) directly reflects the algorithm's performance (the BD Veritor system's interpretation) without human intervention in the result determination once the sample is loaded.

7. The Type of Ground Truth Used

The ground truth used was an FDA-cleared Influenza A and B molecular assay (PCR).

8. The Sample Size for the Training Set

The document does not explicitly separate or mention a training set sample size for the device's algorithms. The clinical study samples (736 specimens) are identified as the test set for performance evaluation. For a point-of-care immunoassay with an optical reader, the algorithms are typically developed and validated internally during the device's development phase, rather than through external "training sets" in the typical machine learning sense for image analysis.

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

As a training set is not explicitly referred to in the document, how its ground truth was established is not detailed. However, for diagnostic devices, the development of algorithms would typically involve internal validation using characterized samples with known influenza status, likely determined by methods such as viral culture or validated molecular assays.

Summary

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BD Veritor 100 System for Rapid Detection of Flu A+B Point of Care

CONFIDENTIAL AND PROPRIET

OCT 2 8 2011

510(k) SUMMARY

SUBMITTED BY:	BECTON, DICKINSON AND COMPANY11085 North Torrey Pines Road, Suite 210La Jolla, CA 92037Phone: 858-795-7890Fax: 858-795-7885
CONTACT NAME:	Gregory Payne
DATE PREPARED:	October 25, 2011
DEVICE TRADE NAME:	BD Veritor™ System for Rapid Detection of Flu A+B
DEVICE COMMON NAME:	Influenza virus serological reagents
DEVICE CLASSIFICATION:	21 CFR § 866.3330
PREDICATE DEVICES:	Quidel QuickVue Influenza A+B

INTENDED USE:

Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.

If infection with a novel influenza 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 the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

DEVICE DESCRIPTION:

BD Diagnostic Systems Becton, Dickinson and Company

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DEVICE COMPARISON:

The BD Veritor™ System for Rapid Detection of Flu A+B was compared to the QuickVue Influenza A+B test (K053146 and K092698).

Product Feature	BD Veritor™ System for Flu A+B (K112277)	Quidel QuickVue Influenza A+B (K053146)
Intended Use	The BD Veritor™ System for Rapid Detection ofFlu A+B is a rapid chromatographicimmunoassay for the direct and qualitativedetection of influenza A and B viral nucleoproteinantigens from nasopharyngeal and nasal swabsof symptomatic patients. The BD Veritor Systemfor Rapid Detection of Flu A+B is a differentiatedtest, such that influenza A viral antigens can bedistinguished from influenza B viral antigens froma single processed sample using a single device.The test is to be used as an aid in the diagnosisof influenza A and B viral infections. A negativetest is presumptive and it is recommended thatthese results be confirmed by viral culture or anFDA-cleared influenza A and B molecular assay.Negative test results do not preclude influenzaviral infection and should not be used as the solebasis for treatment or other patient managementdecisions. The test is not intended to detectinfluenza C antigens.Performance characteristics for influenza A andB were established during January throughMarch of 2011 when influenza viruses A/2009H1N1, A/H3N2, B/Victoria lineage, andB/Yamagata lineage were the predominantinfluenza viruses in circulation according to theMorbidity and Mortality Weekly Report from theCDC entitled "Update: Influenza Activity-UnitedStates, 2010-2011 Season, and Composition ofthe 2011-2012 Influenza Vaccine." Performancecharacteristics may vary against other emerginginfluenza viruses.If infection with a novel influenza virus issuspected based on current clinical andepidemiological screening criteria recommendedby public health authorities, specimens should becollected with appropriate infection controlprecautions for novel virulent influenza virusesand sent to the state or local health departmentfor testing. Virus culture should not be attemptedin these cases unless a BSL 3+ facility isavailable to receive and culture specimens.	The QuickVue® Influenza A+B test allows forthe rapid, qualitative detection of influenzatype A and type B antigens directly from nasalswab, nasopharyngeal swab, nasal aspirate,and nasal wash specimens. The test isintended for use as an aid in the rapiddifferential diagnosis of acute influenza type Aand type B viral infections. The test is notintended to detect influenza C antigens.Negative results should be confirmed by cellculture; they do not preclude influenza virusinfection and should not be used as the solebasis for treatment or other managementdecisions. The test is intended for professionaland laboratory use.
SpecimenTypes	Nasopharyngeal and nasal swabs	Nasal swab, nasopharyngeal swab, nasalwash/aspirate
AssayTechnology	Immunochromatographic	Immunochromatographic
DetectionFormat	An opto-electronic reader determines the lineintensity at each of the spatially-defined test andcontrol line positions, interprets the results usingthe scoring algorithm, and reports a positive,negative, or invalid result on the LCD screenbased on pre-set thresholds.	Visual determination of presence or absenceof pink-to-red Test Line and the appearance ofa blue Procedural Control Line on the test stripindicate the presence of influenza A and/or Bantigen.
Qualitative	Yes	Yes
Total AssayTime	Approximately 10 minutes	Less than 15 minutes
Control format	• Kit Flu A+/B- dry swab procedural control• Kit Flu B+/A- dry swab procedural control• Internal positive control• Internal negative control	• Kit Flu A+ control swab• Kit Flu B+ control swab• Kit Negative control swab• Internal control lines
Detection ofFlu A and Bviruses	Differentiated influenza A and influenza B	Differentiated influenza A and influenza B

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SUMMARY OF PERFORMANCE DATA:

Analytical Sensitivity

The limit of detection (LOD) for the BD Veritor System for Rapid Detection of Flu A+B test was established for a total of 7 influenza strains: 4 influenza A and 3 influenza B. The LOD for each strain represents the lowest concentration producing

a positivity rate of approximately 95% based on testing 20 to 60 replicates.

Type	Influenza Viral Strain	CalculatedLOD(TCID50/mL)	No.Positive/ Total	%Positive
A	A/Brisbane/10/2007 H3N2	$7.27 x 10^2$	57/60	95%
A	A/Brisbane/59/2007 H1N1	$3.30 x 10^2$	57/60	95%
A	A/California/7/2009 H1N1	$5.00 x 10^3$	57/60	95%
A	A/Victoria/3/75 H3N2	$3.11 x 10^3$	59/60	98.3%
B	B/Brisbane/60/2008	$7.42 x 10^3$	58/60	96.7%
B	B/Florida/4/2006	$1.30 x 10^3$	58/60	96.7%
B	B/Lee/40	$4.44 x 10^4$	20/20	100%

TCID50/mL = 50% Tissue Culture Infectious Dose

Analytical Specificity

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A panel of 52 influenza viral strains including 20 Influenza A strains and 32 Influenza B strains were evaluated in triplicate with the BD Veritor ™ System for Rapid Detection of Flu A+B test. All Influenza A viruses and all Influenza B viruses were correctly detected by the test.

Cross Reactivity

A total of 51 microorqanisms (37 bacteria, one yeast and 14 viruses) were tested in triplicate with the BD Veritor™ System for Rapid Detection of Flu A+B test. None of the microorganisms tested were shown to be cross reactive with the test.

Interfering Substances

A variety of substances including whole blood, prescription medications and over-the-counter (OTC) medications, were tested with the BD Veritor™ System for Rapid Detection of Flu A+B test in triplicate at concentration levels comparable to or greater than levels that may be resent in patient respiratory samples. None of the substances evaluated were shown to interfere with the performance of the test.

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CLINICAL STUDIES

Reproducibility

The reproducibility of the BD Veritor System for Rapid Detection of Flu A+B test was evaluated at three POC sites. The reproducibility panel was composed of 30 simulated influenza A or B samples. These included moderate positive samples, low positive samples (near the assay limit of detection), high negative samples (i.e., containing very low concentrations of virus such that positive results occur ~5% of the time) and negative samples. The results are summarized below.

Reproducibility Results - Percent of Flu A Positives
Sample	P1	P4	P5	Total
High negativeH1N1 A	0% (0/30)(0%, 11.3%)	10% (3/30)(3.5%, 25.6%)	26.7% (8/30)(14.2%, 44.4%)	12.2% (11/90)(7%, 20.6%)
Low positiveH1N1 A	86.7% (26/30)(70.3%, 94.7%)	96.7% (29/30)(83.3%, 99.4%)	100% (30/30)(88.6%, 100%)	94.4% (85/90)(87.6%, 97.6%)
Moderatepositive H1N1 A	100% (30/30)(88.6%, 100%)	100% (30/30)(88.6%, 100%)	100% (30/30)(88.6%, 100%)	100% (90/90)(95.9%, 100%)
High negativeH3N2 A	0% (0/30)(0%, 11.3%)	10% (3/30)(3.5%, 25.6%)	16.7% (5/30)(7.3%, 33.6%)	8.9% (8/90)(4.6%, 16.6%)
Low positiveH3N2 A	100% (30/30)(88.6%, 100%)	93.3% (28/30)(78.7%, 98.2%)	96.7% (29/30)(83.3%, 99.4%)	96.7% (87/90)(90.7%, 98.9%)
Moderatepositive H3N2 A	100% (30/30)(88.6%, 100%)	100% (30/30)(88.6%, 100%)	100% (30/30)(88.6%, 100%)	100% (90/90)(95.9%, 100%)
Negatives	0% (0/119)(0%, 3.1%)	0.8% (1/119)(0.1%, 4.6%)	0% (0/119)(0%, 3.1%)	0.3% (1/357)(0%, 1.6%)

Reproducibility Results - Percent of Flu B Positives
Sample	P1	P4	P5	Total
High negativeB	0% (0/30)(0%, 11.3%)	3.3% (1/30)(0.6%, 16.7%)	26.7% (8/30)(14.2%, 44.4%)	10% (9/90)(5.4%, 17.9%)
Low positive B	73.3% (22/30)(55.6%, 85.8%)	90% (27/30)(74.4%, 96.5%)	90% (27/30)(74.4%, 96.5%)	84.4% (76/90)(75.6%, 90.5%)

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Reproducibility Results - Percent of Flu B Positives
Sample	P1	P4	P5	Total
Moderatepositive B	100% (29/29)(88.3%, 100%)	96.6% (28/29)(82.8%, 99.4%)	100% (29/29)(88.3%, 100%)	98.9% (86/87)(93.8%, 99.8%)
Negatives	0% (0/210)(0%, 1.8%)	1.0% (2/210)(0.3%, 3.4%)	0% (0/210)(0%, 1.8%)	0.3% (2/630)(0.1%, 1.2%)

Clinical Performance .

Clinical Performance:

Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established in multi-center Point-of-Care (POC) studies conducted at five U.S. trial sites and eight Japan trial sites during the 2010-2011 respiratory season. A total of 736 prospective specimens (515 in the U.S and 221 in Japan) were evaluated using the BD Veritor System for Rapid Detection of Flu A+B test and PCR. These specimens consisted of nasopharyngeal and nasal swabs from symptomatic patients. In the U.S. 54% of the samples were from females with 46% from males. 20.3% were from patients less than or equal to 5 years of age. 40.8% of the patients tested were in the 6-21 year age group, 35.6% were from 22-59 years of age and the remaining 3.3% were obtained from people greater than or equal to age 60. In Japan, 43.3% of the samples were from females with 56.7% from males. 27.3% of the samples were from patients less than or equal to 5 years of age. 58.4% were from patients in the 16-21 year age group. 13.1% from 22-59 years of age and 1.3% were obtained from people greater than or equal to age 60.

The performance of the BD Veritor System for Rapid Detection of Flu A+B test at the U.S. sites were compared to an FDA cleared Influenza A and B molecular assay and are presented in Table 1 through Table 3.

Table 1: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B
Test Compared to PCR for All Swabs - U.S. Sites

	ReferencePCR
POC:BD FluA	P	N	Total
P	122	8	130
N	33*	352	385
Total	155	360	515
Reference Method: PCRPPA: 78.7% (95% C.I. 71.6%, 84.4%)

NPA: 97.8% (95% C.I. 95.7%, 98.9%)

		Reference PCR
POC:BD FluB	P	N	Total
P	75	ನ	77
N	26**	412	438
Total	101	414	515
Reference Method: PCR
PPA: 74.3% (95% C.I. 65%, 81.8%)
NPA: 99.5% (95% C.I. 98.3%, 99.9%)

Of the 33 PCR positive, BD Veritor negative Influenza A specimens, eight were positive in the BD Veritor assay using a second swab specimen (reference method specimen) collected from the same patient.

BD Diagnostic Systems Becton, Dickinson and Company

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** Of the 26 PCR positive, BD Veritor negative Influenza B specimens, six were positive in the BD Veritor assay using a second swab specimen (reference method spcimen) collected from the same patient.

Table 2: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for Nasopharyngeal Swabs - U.S. Sites

	ReferencePCR
POC:BD Flu A	P	N	Total
P	53	5	58
N	18	135	153
Total	71	140	211
Reference Method: PCR
PPA: 74.6% (95% C.I. 63.4%-83.3%)
NPA: 96.4% (95% C.I. 91.9%-98.5%)
	Reference PCR
POC.BD FluB	P	N	Total
P	22	1	23
N	8	180	188
Total	30	181	211
Reference Method: PCR
PPA: 73.3% (95% C.I. 55.6%-85.8%)
NPA: 99.4% (95% C.I. 96.9%-99.9%)

Table 3: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for Nasal Swabs - U.S. Sites

	ReferencePCR
POC:BD FluA	P	N	Total
p	ലു	3	72
N	15	217	232
Total	84	220	304
Reference Method: PCR
PPA: 82.1% (95% C.I. 72.6%, 88.9%)
NPA: 98.6% (95% C.I. 96.1%, 99.5%)
		Reference PCR
POC:BD FluB	P	N	Total
P	53	1	54
N	18	232	250
Total	71	233	304
Reference Method: PCR
PPA: 74.6% (95% C.I. 63.4%-83.3%)
NPA: 99.6% (95% C.I. 97.6%-99.9%)

The performance of the BD Veritor System for Rapid Detection of Flu A+B test at the Japan sites were also compared to an FDA cleared Influenza A and B molecular assay and are presented in Table 4 through Table 6.

Table 4: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for all Swabs - Japan Sites

	ReferencePCR
POC:BD FluA	P	N	Total
P	67	5	72
N	4	145	149
Total	71	150	221
	Reference PCR
POC:BD FluB	P	N	Total
P	64	8	72
N	6	143	149
Total	70	151	221

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	ReferencePCR
POC:BD FluA	P	N	Total
Reference Method: PCRPPA: 94.4% (95% C.I. 86.4%-97.8%)NPA: 96.7% (95% C.I. 92.4%-98.6%)
	Reference PCR
POC:BD FluB	P	N	Total
Reference Method: PCR
PPA: 91.4% (95% C.I. 82.5%-96%)
NPA: 94.7% (95% C.I. 89.9%-97.3%)

Table 5: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for all Nasopharyngeal Swabs - Japan Sites

	Reference PCR
POC:BD FluA	P	N	Total
P	30	1	31
N	2	83	85
Total	32	84	116
Reference Method: PCR
PPA: 93.8% (95% C.I. 79.9%-98.3%)
NPA: 98.8% (95% C.I. 93.6%-99.8%)
	Reference PCR
POC:BD FluB	P	N	Total
P	38	2	40
N	1	75	76
Total	39	77	116
Reference Method: PCR
PPA: 97.4% (95% C.I. 86.8%-99.5%)
NPA: 97.4% (95% C.I. 91%-99.3%)

Table 6: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for Nasal Swabs – Japan Sites

	Reference PCR				Reference PCR
POC:BD FluA	P	N	Total	POC:BD FluB	P	N	Total
P	37	4	41	P	26	6	32
N	2	62	64	N	5	68	73
Total	39	66	105	Total	31	74	105
Reference Method: PCRPPA: 94.9% (95% C.I. 83.1%-98.6%)NPA: 93.9% (95% C.I. 85.4%-97.6%)				Reference Method: PCRPPA: 83.9% (95% C.I. 67.4%-92.9%)NPA: 91.9% (95% C.I. 83.4%-96.2%)

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, flowing design.

10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 2 8 2011

Becton, Dickinson and Company c/o Gregory P. Payne, RAC Director, Quality Systems and Regulatory Affairs 10865 Road to the Cure, Suite 200 San Diego, CA 92121

Re: K112277

Trade/Device Name: BD Veritor " System for the Rapid Detection of Flu A + B Regulation Number: 21 CFR& 866.3330 Regulation Name: Influenza Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: September 30, 2011 Received: October 3, 2011

Dear Mr. Payne:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Greg Payne

notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. 1

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Uue Scif for

Sally A. Hoivat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: BD Veritor™ System for Rapid Detection of Flu A+B

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Yauwan Hielddl
Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

astic Systems K //227 Becton kirrson and Ge

Regulation Number and Section

§ 866.3328 Influenza virus antigen detection test system.

(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.