The Binax NOW® RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncycial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal swab specimens from sympromatic patients. This test is intended for in virro diagnostic use to aid in the diagnosis of RSV infections in neonatal and pediatric patients under the age of five. It is recommended that negative test results be confirmed by culture.

Device Description

The Binax NOW RSV Test is an immunochromatographic membrane assay used to detect RSV antigen in nasopharyngeal specimens. A test scrip, containing gold-conjugated and immobilized and -RSV ancibodies, is mounted on the right side of a cardboard, book-shaped hinged test device. Swab specimens and patients) require a sample preparation seep, in which the sample is eluted off the swab into transport media or saline. Nasal wash samples do not require any preparation. The sample to be tested is added to a pad at the top of the rest strip, and the rest device is closed. RSV antigen present in the sample reacts to bind anti-RSV conjugated antibody. The resulting antigen-conjugate complexes are captured by immobilized anti-RSV antibody, forming the Sample Line Immobilized Control Line antibody, which appears as a blue line in an uncested device, captures a visualizing conjugate, forming a pink Control Line. The sample is contained, and results are available within 15 minutes.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Binax NOW® RSV Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria as numerical targets. Instead, the study aims to establish "substantial equivalence" to a predicate device. The performance is reported in terms of sensitivity and specificity against viral cell culture (or DFA/viral cell culture for nasopharyngeal swabs). We can infer the "acceptance criteria" were implied to be comparable performance to existing methods.

Test Type	Performance Metric	Reported Performance
Nasal Wash (Retrospective)	Sensitivity	Not explicitly stated in a tabular format, but implied to be high based on "NOW® test performance versus viral cell culture... was calculated". The accompanying table is unreadable.
	Specificity	Not explicitly stated.
Nasal Wash (Prospective)	Sensitivity	Not explicitly stated in a tabular format. The accompanying table is unreadable.
	Specificity	Not explicitly stated.
Nasopharyngeal Swab	Sensitivity	Not explicitly stated in a tabular format. The accompanying table is unreadable.
	Specificity	Not explicitly stated.
Analytic Reactivity	Detection	Positive for 6 subgroup A and 5 subgroup B clinical isolates of RSV.
Analytic Specificity	Cross-reactivity	No cross-reactivity with 48 potential cross-reactants (bacteria and viruses) at specified concentrations, except for Palivizumab.
Reproducibility	Correct Interpretation	100% of 234 samples correctly interpreted across 3 sites.

2. Sample Sizes and Data Provenance

Nasal Wash - Retrospective Study:

Sample Size: 59 viral cultured nasal wash specimens.
Data Provenance: Obtained from a teaching university/medical center in the northeast (USA, presumably). Retrospective.

Nasal Wash - Prospective Study:

Sample Size: 191 nasal wash specimens.
Data Provenance: Multi-center, prospective study. Country of origin not specified, but context suggests USA.

Nasopharyngeal Swab - Prospective Study:

Sample Size: 179 nasopharyngeal swab specimens.
Data Provenance: Multi-center, prospective study. Country of origin not specified, but context suggests USA.

Reproducibility Study:

Sample Size: 234 coded specimens (panel containing negative, low positive, and low/moderate positive controls).
Data Provenance: Blind study conducted at 3 separate sites. Country of origin not specified, but context suggests USA.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish the ground truth (viral cell culture or DFA/viral cell culture). It only states that performance was calculated "using standard methods."

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any analysis of how human readers improve with AI vs without AI assistance. The device is an immunochromatographic assay, not an AI-powered diagnostic.

6. Standalone (Algorithm Only) Performance

The device is a rapid immunochromatographic assay. The reported clinical sensitivity and specificity studies reflect the standalone performance of the device (algorithm only, as there is no human interpretation component beyond reading the visible lines).

7. Type of Ground Truth Used

Clinical Studies (Nasal Wash): Viral cell culture.
Clinical Studies (Nasopharyngeal Swab): DFA/viral cell culture (Direct Fluorescent Antibody / viral cell culture).

8. Sample Size for the Training Set

The document does not specify a separate training set size. The device is a lateral flow immunoassay, not a machine learning algorithm that typically requires a large training dataset in the same way. The development and optimization of the assay would involve internal validation and development studies, but these are not referred to as statistical "training sets" in this context.

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

Given that this is an immunochromatographic assay and not an AI/machine learning device, the concept of a "training set" with ground truth established in the typical sense for algorithms is not applicable. The development of such a device involves:

Selection and optimization of antibodies and reagents.
Establishing critical concentrations and cutoff points through empirical testing with known positive and negative samples (controls, characterized clinical isolates).
Analytic reactivity and specificity testing (as mentioned in the summary) to ensure proper functioning.

The "ground truth" for these development phases would be based on well-characterized viral isolates, clinical samples confirmed by reference methods (like cell culture), and purified substances.

Summary

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OCT 2 1 2003

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Viral Answirs For Better Health. . NOW"

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: K032166

SUBMITTER:	Binax, Inc.217 Read StreetPortland, Maine 04103(207) 772-3988 (Office)(207) 871-5751 (FAX)
CONTACT PERSON:	Pamela S. Angellpangell@binax.com (email)
TRADE NAME:	Binax NOW® RSV Test
COMMON NAME:	RSV ICT, Binax NOW® RSV test
CLASSIFICATION NAME:	Antigen, CF (including CF Controls), Respiratory Syncyctial Virus (per 21CFR 866.3480)
PREDICATE DEVICE:	BD Directigen™ EZ RSV Test, 510(k) #K022133

DEVICE DESCRIPTION:

INTENDED USE:

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TECHNOLOGICAL CHARACTERISTICS:

Both the Binax NOW® RSV Test and the BD Directigen™ EZ RSV test are simple rapid immunochromatographic assays utilizing colloidal gold conjugate and an antibody striped membrane to caprure and visualize antigen.

PERFORMANCE SUMMARY:

The Binax NOW® RSV Test has already been determined to be subscantially equivalent (SE) to the BD RSV Test (K882629) for the derection of RSV in nasal wash specimens. Data supporting this SE determination was presented in the original 510(k) K021687 and is included in the following summary. New data presented in the Performance Section of this application, and summarized below, establishes SE of the NOW RSV test to the BD EZ RSV test (K022133) when testing nasopharyngeal swab specimens.

Analytic Reactivity (as reported in original 510(k) K021687):

There are two known subgroups of respiratory syncytial virus (RSV) and both contain the conserved fusion procen targeted by the Binax NOW® test: Six (6) subgroup A clinical isolates and five (5) subgroup B clinical isolates tested were positive in the Binax NOW® test.

Analytic Specificity (Cross-Reactivity):

To demonstrate the immunologic specificity of the Binax NOW® cest, 48 porential coss-reactants were tested in the Binax NOW test. The cross-reactant pand included bacceria and viruses that may be present in respiratory specimens. Bacreda rested at concentrations greater than 1 x 10° organisms/ml and viruses rested at concentrations greater than 1 x 10 TCIDsyml did not cross-react in the Binax NOW Test. Merapheumovirus was rested at a concentration of 2x 10 TCIDsy/ml and did not cross-react.

Nasal Wash - Clinical Sensitivity and Specificity (as reported in original 510(k) K021687):

The Binax NOW RSV Test was evaluated in both retrospective and prospective clinical studies.

Retrospective Study

Fifty nine (59) viral cultured nasal wash specimens, obrained from a teaching university/medical center in the northeast, were tested in the NOW® test. NOW® test performance versus viral cell culture (including 95% confidence intervals) was calculated using standard methods.


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In a multi-center prospective study, the Binax NOW test was used to evaluate 191 nasal wash specimens collected from patients presenting with RSV-like symptoms. NOW test performance versus viral cell culture (including 95% confidence intervals) was calculated using standard methods.

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Nasopharyngeal Swab - Clinical Sensitivity and Specificity.

In a multi-center prospective study, the Binax NOW® test was used to evaluate 179 nasopharyngeal swab specimens collected from patients presenting with RSV-like symproms. NOW test performance versus DFA/viral cell culture (including 95% confidence intervals) was calculated using standard methods.

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Interfering Substances

The Binax NOW rest was found not to cross-react with 17 of 18 subscances that may be artificially introduced into the nasal cavity or nasopharynx or that are naturally present in respiratory specimens. Each potentially inteffering substance was difuted to the appropriate concentration in a saline BSA solution and tested in the Binax NOW® Test. A portion of each of these solucions was also spiked with the limit of derection (LOD) level of a viable RSV before testing in the Binax NOW® Test. All substance generated expected results in the Binax NOW® Test, with the exception of the antiviral Palivisumab, which interefered with Binax NOW® Test decection of RSV.

Reproducibility (as reported in original 510(k) K021687):

A blind study of the Binax NOW® test was conducted at 3 separate sites using a parel of coded specimens containing negative, low positive (LOD), and low/moderate positive controls. Participants performed testing on 3 different days. One hundred percent (100%) of the 234 samples tested were correctly interpreted.

Product Stability.

Stability studies of the Binax NOW® RSV Test and kit controls support the assigned expiry dating.

References:

Lopca, Juan A, R. Bustos, C. Orvell, M. Berois, J. Arbiza, B. Garcia-Barreno, J. Melero. Antigenic Structure of Human Respiratory Syncytial Virus Fusion Glycoprotein. Jr. of Virology, vol. 72, no. 8, August 1998, pp. 6922-6928

Signed Pamela S. Angell Date 10|20|03
Pamela S. Angell
Regulatory Manager

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 2 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Public Health Service

Ms. Pamela Angell Regulatory Manager Binax, Inc. 217 Read Street Portland. ME 04103

Re: K032166

Trade/Device Name: BINAX NOW® RSV Test Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory Syncytial Virus Serological Reagents Regulatory Class: Class I Product Code: GOG Dated: September 15, 2003 Received: October 14, 2003

Dear Ms. Angell:

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 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); 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 notification. The FDA finding of substantial equivalence of your device to a legally

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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 marketed 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Binax NOW® RSV Test 510(k) Notification

Revision 7/14/03

INDICATIONS FOR USE ENCLOSURE

K032166

510(k) Number (if known):

Device Name:

Binax NOW® RSV Test

Indications For Use:

The Binax NOW® RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. This test is intended for in virro diagnostic use to aid in the diagnosis of RSV infections in neonatal and pediatric patients under the age of five. It is recommended that negative test results 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)

Division Sign-Off	signature 10/20/03
-------------------	---------------------------

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)	K032166
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Prescription Use	✓	OR	Over-The-Counter Use	_
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.3480 Respiratory syncytial virus serological reagents.

(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.