The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.

Device Description

The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in nasopharyngeal specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, bookshaped hinged test device.

Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

AI/ML Overview

Here's an analysis of the provided text regarding the BinaxNOW® Influenza A & B Test, focusing on acceptance criteria, study details, and data provenance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BinaxNOW® Influenza A & B Test are implicitly derived from its comparison to a clinical reference method (cell culture/DFA) and to its predicate devices (Binax NOW® Flu A Test and Binax NOW® Flu B Test). The study aimed to demonstrate acceptable sensitivity and specificity.

Metric (vs. Culture/DFA)	Acceptance Criteria (Implied)	Reported Device Performance
Influenza A:
Sensitivity	High relative to clinical need	75% (3/4)
Specificity	High	100% (110/110)
Influenza B:
Sensitivity	High relative to clinical need	50% (1/2)
Specificity	High	100% (112/112)

Metric (vs. NOW® Flu A Test)	Acceptance Criteria (Implied)	Reported Device Performance
Influenza A:
Sensitivity	High	100%
Specificity	High	96%

Metric (vs. NOW® Flu B Test)	Acceptance Criteria (Implied)	Reported Device Performance
Influenza B:
Sensitivity	High	93%
Specificity	High	97%

Note: The document does not explicitly state numerical acceptance criteria in the typical "must achieve X% sensitivity and Y% specificity" format. Instead, the performance is presented to demonstrate substantial equivalence to established methods and predicate devices. The clinical study against culture/DFA has very small numbers of positive cases, leading to wide confidence intervals and potentially lower apparent sensitivity. The studies against the predicate Binax NOW® Flu A and B tests show much stronger performance, suggesting the extended claim focuses on maintaining equivalence to those previously cleared devices.

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

Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA):
- Sample Size: 114 specimens (113 NP swab, 1 wash/aspirate).
- Data Provenance: Prospective study conducted in 2004 outside the US. Specimens collected from children (<18 years) and adults (>=18 years) presenting with influenza-like symptoms.
Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests):
- Sample Size: 306 retrospective frozen clinical samples for Flu A comparison; 303 retrospective frozen clinical samples for Flu B comparison.
- Data Provenance: Retrospective frozen clinical samples. Collected from symptomatic patients at multiple physician offices, clinics, and hospitals in the Southern, Northeastern, and Midwestern regions of the United States, and one hospital in Sweden.
Clinical Study (Binax NOW® Flu A and Flu B Test Performance vs. Cell Culture - for predicate devices):
- Sample Size: 373 prospective clinical samples.
- Data Provenance: Multi-center prospective study conducted during the 2002 Flu season at physician offices and clinics in the Western and mid-Atlantic United States.

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

The document does not specify the number or qualifications of experts used to establish the ground truth.

For the prospective study comparing the BinaxNOW® combined test to cell culture/DFA, "cell culture and/or DFA" serves as the reference standard (ground truth). It is assumed these reference methods were performed by qualified laboratory personnel, but no specifics are given.
For the retrospective study comparing the BinaxNOW® combined test to the individual NOW® Flu A and Flu B Tests, those individual tests are treated as the reference standard.
For the predicate device studies, "cell culture" served as the reference.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the test set. It mentions that "Test results are interpreted at 15 minutes based on the presence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay." This suggests a single interpretation per device, without multi-reader adjudication outlined. For the analytical sensitivity, 12 different operators interpreted devices to determine the LOD.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) rapid immunoassay, not an AI-assisted diagnostic tool for interpretation by human readers. The output is a visual presence or absence of a line on a test strip.

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

Yes, the performance data presented are for the device (the BinaxNOW® Influenza A & B Test) as a standalone diagnostic tool. It is a rapid immunoassay that outputs a visual result, which is then interpreted by a human, but the performance metrics provided (sensitivity, specificity) reflect the device's ability to detect the antigen itself, not the human interpreter's performance. The analytical studies (analytical sensitivity, reactivity testing, analytical specificity) are also standalone performance evaluations of the device.

7. The Type of Ground Truth Used

Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA): Cell Culture and/or Direct Fluorescent Antibody (DFA). This is a laboratory-based reference standard.
Clinical Study (BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests): The individual Binax NOW® Flu A and Flu B Tests (predicate devices) were used as the reference standard.
Clinical Study (Binax NOW® Flu A and Flu B Test Performance vs. Cell Culture - for predicate devices): Cell Culture.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development (e.g., machine learning training). As a rapid immunoassay, this device relies on biological interactions (antibody-antigen binding) rather than a trained algorithm. The various analytical and clinical studies serve to validate its performance.

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

Not applicable, as there is no mention of a "training set" in the machine learning sense for this immunochromatographic device. The development and optimization of such assays would involve extensive in-house testing using characterized positive and negative samples, but these are not typically referred to as a "training set" in the regulatory context for IVDs.

Summary

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NOV 3 0 2005

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:	K025312
--------------------------------	---------

The purpose of this 510(k) submission is to expand the Analytical Reactivity claims of the currently 510(k) cleared BinaxNOW® Influenza A & B Test (510(k) #K041049).

SUBMITTER

Binax, Inc. 10 Southgate Road Scarborough, Maine 04074 (207) 730-5700 (Office) (207) 730-5710 (FAX)

CONTACT PERSON

Angela Drysdale angela.drysdale@binax.com {email)

DATE PREPARED

November 04, 2005

TRADE NAME

BinaxNOW® Influenza A & B Test

COMMON NAME

NOW® Flu A/B Test, NOW® Influenza A/B, NOW® Influenza A & B, Binax NOW® Influenza A & B, Binax NOW® Influenza A/B

CLASSIFICATION NAME

Antigen, CF (including CF Controls), Influenza Virus A, B, C (per 21 CFR 866.3330)

PREDICATE DEVICES

Binax NOW® Influenza A & B Test; K041049 Binax NOW® Flu A Test; K021649 Binax NOW® Flu B Test: K021646

DEVICE DESCRIPTION:

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INTENDED USE

TECHNOLOGICAL CHARACTERISTICS

The Expanded Claim BinaxNOW® Influenza A & B Test is exactly the same as the currently 510/k) cleared BinaxNOW® Influenza A & B Test. Both tests use identical lateral flow immunochromatographic technology. Both tests are rapid immunoassays that employ specific antibodies immobilized onto a solid phase to capture and visualize influenza nucleoprotein antigens.

PERFORMANCE SUMMARY

CLINICAL STUDIES

BinaxNOW® Influenza A & B Test Performance vs. Cell Culture / DFA - Prospective Study

The performance of the BinaxNQW® Influenza A & B Test was compared to cell culture and/or DFA, and to the Binax NOW® Flu A Test and the Binax NOW® Flu B Test, in a prospective study conducted in 2004 outside the US. Nasopharyngeal (NP) swab and nasal wash / aspirate specimens, collected at multiple sites from children (less than 18 years of age) and adults (18 years or older) presenting with influenza-like symptoms, were evaluated in the Binax test at a central testing lab.

Forty-seven percent (47%) of the population tested was male, 53% female, 40% pediatric (< 18 years), and 60% adult (> 18 years). No differences in test performance were observed based on patient age or gender. There were no invalid tests reported.

One hundred and thirteen (113) NP swab specimens and 1 wash/aspirate specimen were tested. One hundred and eight (108) of the 114 samples tested were influenza negative by culture/DFA, and 6 samples were influenza positive. When compared to culture/DFA, the BinaxNOW® Test was 75% (3/4) sensitive and 100% (110/110) specific for detection of influenza A and 50% (1/2) sensitive and 100% (112/112) specific for detection of influenza B. There was 100% agreement between the BinaxNOW® Influenza A & B Test and the individual Flu A and Flu B Tests.

BinaxNOW® A & B Test specificity by sample type versus cell culture / DFA, including 95% confidence intervals, is listed below.

BinaxNOW® Influenza A & B Test Specificity vs. Cell Culture/DFA

FLU A SPECIFICITY
Sample	-/+	+/-	% Spec	95% CI
NP Swab	109	0	100%	97-100%
Wash/Aspirate	1	0	100%	16-99%
Overall	110	0	100%	97-100%

FLU B SPECIFICITY
-/-	+/-	% Spec	95% CI
111	0	100%	97-100%
1	0	100%	16-99%
112	0	100%	97-100%

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BinaxNOW® Influenza A & B Test Performance vs. Binax NOW® Flu A and Flu B Tests:

Performance of the BinaxNOW® Influenza A & B Test was compared to the current NOW® Flu A Test on 306 retrospective frozen clinical samples and to the NOW® Flu B Test on 303 retrospective frozen clinical samples. All clinical samples were collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern and Midwestern regions of the United States and from one hospital in Sweden. Fifty-three percent (53%) of the population tested was male, 47% female, 64% pediatric (< 18 years) and 36% adult (≥ 18 years). Nasal wash/aspirate specimens comprised approximately 57% of the samples tested, while NP swabs represented 42%. No differences in test performance were observed based on patient age and gender or based on sample type tested.

The BinaxNOW® Influenza A & B Test was 100% sensitive and 96% specific for detection of influenza A vs. the NOW® Flu A Test and 93% sensitive and 97% specific for detection of influenza B vs. the NOW® Flu B Test. Test performance by virus type (A vs. B), by sample type (swab vs. wash/aspirate), and overall, including 95% confidence intervals, is detailed in the following tables.

	FLU A SENSITIVITY				FLU A SPECIFICITY
Sample	+/+	-/+	% Sens	95% CI	+/-	+/+	% Spec	95% CI
NP Swab	30	0	100%	89-100%	96	1	99%	94-100%
Wash/Aspirate	47	0	100%	93-100%	123	9	93%	88-96%
Overall	77	0	100%	95-100%	219	10	96%	88-96%

Sample	FLU B SENSITIVITY		% Sens	95% CI	FLU B SPECIFICITY		% Spec	95% CI
	+/+	-/+			+/-	-/+
NP Swab	2	0	100%	29-99%	126	1	99%	96-100%
Wash/Aspirate	12	1	92%	66-98%	152	9	94%	90-97%
Overall	14	1	93%	70-98%	278	10	97%	94-98%

Binax NOW® Flu A and Flu B Test Performance vs. Cell Culture

Performance of the Binax NOW® Flu A and Flu B Tests was compared to cell culture on 373 prospective clinical samples collected as part of a multi-center study conducted during the 2002 Flu season at physician offices and clinics located in the Western and mid-Atlantic United States. Fifty-four percent (54%) of the population tested was male, 46% female, 90% pediatric (< 18 years) and 10% adult (≥ 18 years). Nasal wash/aspirates comprised 51% of the samples tested, while NP swabs represented 49%. No differences in performance were observed based on patient age and gender or based on sample type tested.

The Binax NOW® Flu A Test was 80% sensitive and 93% specific while the Binax NOW® Flu B Test was 65% sensitive and 97% specific when compared to cell culture. The performance of the two tests by sample type (swab vs. wash/aspirate) and overall, including 95% confidence intervals, is detailed in the following tables.

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Binax NOW® Flu A Test vs. Cell Culture
	FLU A SENSITIVITY				FLU A SPECIFIC
Sample	+/+	+/-	% Sens	95% CI	-/-	+/-	% Spec
NP Swab	29	8	78%	62-88%	133	12	92%
Wash/Aspirate	40	9	82%	69-90%	133	9	94%
Overall	69	17	80%	71-87%	266	21	93%

Binax NOW Flu B Test vs. Cell Culture

Sample	FLU B SENSITIVITY
	+/+	+/-	% Sens	95% CI
NP Swab	21	15	58%	42-73%
Wash/Aspirate	29	12	71%	56-83%
Overall	50	27	65%	54-75%

FLU B SPECIFICITY
+/-	+/-	% Spec	95% CI
142	4	97%	93-99%
146	4	97%	93-99%
288	8	97%	95-99%

CITY

95% Cl

88-85% 89-97% 89-95%

ANALYTICAL STUDIES

Analytical Sensitivity

The BinaxNOW® test limit of detection (LOD), defined as the concentration of influenza virus that produces positive BinaxNOW test results approximately 95% of the time, was identified by evaluating different concentrations of inactivated Flu A/Beijing and inactivated Flu B/Harbin in the BinaxNOW test.

Twelve (12) different operators each interpreted 2 devices run at each concentration for a total of 24 determinations per level. The following results identify a concentration of 1.03 x 10° ng/ml as the LOD for Flu A/Beijing and 6.05 x 101 ng/ml for Flu B/Harbin.

Influenza A/Beijing
Concentration(ng/ml)	#Detected	%Detected
$1.03 \times 10^2$ (LOD)	23/24	96
$5.60 \times 10^1$ (Cutoff)	*	50
$3.27 \times 10^1$ (High Neg)	4/24	17
True Negative	0/24	0
Influenza B/Harbin
Concentration(ng/ml)	#Detected	%Detected
$6.05 x 10^1$ (LOD)	23/24	96
$2.42 x 10^1$ (Cutoff)	11/24	46
$1.51 x 10^1$ (High Neg)	6/24	25
True Negative	0/24	0

*Linear regression was used to calculate a line equation, which was then used to project the cutoff concentration of Flu A/Beijing.

To demonstrate comparable analytical sensitivity of the BinaxNOW® Influenza A & B Test and the individual NOW® Flu A and Flu B Tests, the Flu A and B cutoff levels identified above were evaluated in the NOW® Flu A and Flu B Tests.

The A/Beijing cutoff sample detected 50% of the time in the BinaxNOW® Influenza A & B Test was also detected 50% (12/24) of the time in the NOW® Flu A Test when tested by six (6) operators interpreting a total of 24 devices. Likewise, the B/Harbin cutoff sample detected 46% of the time in the BinaxNOW® Influenza A & B Test was detected 10% (4/40) of the time in the NOW® Flu B Test when tested by ten (10) operators interpreting 40 devices.

These data demonstrate that the analytical sensitivity of the BinaxNOW® Influenza A & B Test is equivalent or better than that of the individual NOW® Flu A and B Tests.

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Avian Influenza (H5N1) Analytical Reactivity Testing

The two (2) live avian influenza (H5N1) strains isolated from humans listed below tested positive in the BinaxNOW Influenza A & B Test at concentrations ranging from 10-10 TCIDstml.

Avian Influenza Strain	Concentration
A/Hong Kong/156/97	1.3 x 102
A/Vietnam/1194/04	1.0 x 104

Reactivity Testing

The seven (7) live influenza A strains and five (5) live influenza B strains listed below tested positive in the BinaxNOW® Influenza A & B Test at concentrations ranging from 10'-10' CEIDss/ml. Atthough the specific influenza strains causing infection in humans can vary year to year, all contain the conserved nucleoproteins targeted by the BinaxNOW® test.

Influenza Strain	ATCC
Flu A/NWS/33	VR-825
Flu A/NWS/33	VR-215
Flu A/Hong Kong/8/68	VR-544
Flu A/Aichi/2/68	VR-547
Flu A/New Jersey/8/76	VR-897
Flu A/Mal/302/54	VR-98
Flu A/Port Chalmers/1/73	VR-810
Flu B/Lee/40	VR-101
Flu B/Brigit	VR-786
Flu B/Russia/69	VR-790
Flu B/Hong Kong/5/72	VR-791
Flu B/R75	VR-789

Analytic Specificity (Cross-Reactivity)

To determine the analytical specificity of the BinaxNOW® Influenza A & B Test, 36 commensal and pathogenic microorganisms (27 bacteria, 8 viruses and 1 yeast) that may be present in the nasal cavity or nasopharynx were tested. All of the following microorganisms were negative when tested at concentrations ranging from 104 to 10 TCIDs /ml (viruses), 10' to 108 organisms/ml (bacteria) and 10° organisms/ml (yeast).

Bacteria	Viruses	Yeast
Acinetobacter	Adenovirus	Candida albicans
Bordetella pertussis	Coronavirus
Enterococcus faecalis	Coxsackie B4
Escherichia coli	Cytomegalovirus (CMV)
Gardnerella vaginalis	Parainfluenza 1
Haemophilus influenzae	Parainfluenza 2
Klebsiella pneumoniae	Parainfluenza 3
Lactobacillus casei	Respiratory Syncytial Virus (RSV)
Legionella pneumophila
Listeria monocytogenes
Moraxella catarrhalis
Neisseria gonorrhoeae
Neisseria meningitidis
Neisseria sicca
Neisseria subflava
Proteus vulgaris
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Staphylococcus aureus
(Cowan protein A producing strain)
Staphylococcus epidermidis
Streptococcus, Group A
Streptococcus, Group B

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Streptococcus, Group C Streptococcus, Group F Streptococcus mutans Streptococcus pneumoniae

Interfering Substances

The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated in the BinaxNOW® Influenza A & B Test at the concentrations listed and were found not to affect test performance. Whole blood (1%) did not interfere with the interpretation of negative BinaxNOW® test results, but did interfere with the interpretation of Flu A LOD positive samples. Therefore, visibly bloody samples may not be appropriate for use in this test.

Substance 1 OTC mouthwash 3 OTC nasal sprays 3 OTC throat drops 2 OTC throat sprays 4-acetamidophenol Acetylsalicylic acid Albuterol Chlorpheniramine Dextromethorphan Diphenhydramine Guaiacol glycerol ether Oxymetazoline Phenylephrine Phenylpropanolamine Rebetol Relenza Rimantadine Synagis Tamiflu

Concentration 20% ારત જિલ્લાના એક એવા ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પાદન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા નદર્ભ 20% 10 ma/ml 15 mg/ml 20 mg/ml 5 mg/ml 10 mg/ml 5 mg/ml 20 mg/ml 0.05% 50 mg/ml 20 mg/ml 500 ng/ml 20 mg/ml 500 ng/ml 0.1 mg/ml 50 mg/ml

Transport Media

The following transport media were tested in the BinaxNOW® Influenza A & B Test as negative samples (no virus present) and after inoculation with the LOD levels of Influenza A & B. Media did not impact BinaxNOW test performance, with the media alone testing negative in the NOW test and media inoculated with LOD Influenza A & B testing positive on the appropriate test line in BinaxNOW" test.

Amies Media Hank's Balanced Salt Solution M4 Media M4-RT Media M5 Media Stuart's Media Saline

Reproducibility

A blind study of the BinaxNOW® Influenza A & B Test was conducted at 3 separate sites using panels of blind coded specimens containing negative, low positive, and moderate positive samples. Participants tested each sample multiple times on 3 different days. There was 97% (242/250) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (3 different days) or between sites (3 sites),

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Signed
Rita Calnan

Date _ 04-Nov-2005

Rita Calnan Director of Quality & Regulatory Affairs

Dowdle, W.R., Kendal, A.P., and Noble, G.R. 1980. Influenza Virus, p 836-884. Manual of Clinical Microbiology, 3rd
edition, In Lennette, et. Al (ed.). American So

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of four stylized, curved lines that resemble a human figure or a flame. The text is in all capital letters.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 3 0 2005

Ms. Angela Drysdale Clinical Affairs Specialist Binax, Inc. 10 Southgate Road Portland, Maine 04103

Re: K053126

Trade/Device Name: BinaxNOW® Influenza A & B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class II Product Code: GNX Dated: November 4, 2005 Received: November 7, 2005

Dear Ms. Drysdale:

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 either class II (Special Controls) or class III (PMA), 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 or any 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sally a Hogg

Sally A. Hojvat, 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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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

K053126

Device Name: BinaxNOW® Influenza A & B Test

Indications For Use:

The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Sal, arl
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510/k)_ K 0 5 312 6 -----

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.