Predicate Devices

Reference Devices

BD RSV Test (K882629)

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a simple immunochromatographic assay with visual interpretation of lines. There is no mention of computational analysis, image processing, or any terms related to AI/ML.

Therapeutic

No
The device is an in vitro diagnostic (IVD) test used to detect the presence of RSV antigen, aiding in the diagnosis of RSV infections. It does not provide any therapeutic intervention or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections".

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical immunochromatographic assay with a test strip, cardboard device, and sample preparation steps, indicating it is a hardware-based in vitro diagnostic device, not software only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in neonatal and pediatric patients under the age of five."

This statement directly indicates that the device is designed to be used outside of the body (in vitro) for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

GOG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasal wash, nasopharyngeal swab

Indicated Patient Age Range

neonatal and pediatric patients under the age of five

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytic Reactivity:
Two known subgroups of respiratory syncytial virus (RSV) were tested: Six (6) subgroup A clinical isolates and five (5) subgroup B clinical isolates. All tested positive in the Binax NOW® test, indicating the test targets the conserved fusion protein.

Analytic Specificity (Cross-Reactivity):
48 potential cross-reactants (bacteria and viruses) were tested. Bacteria at concentrations greater than 1 x 10^6 organisms/ml and viruses at concentrations greater than 1 x 10 TCID50/ml did not cross-react. Metapneumovirus at 2x 10 TCID50/ml also did not cross-react.

Nasal Wash - Clinical Sensitivity and Specificity (as reported in original 510(k) K021687):
Retrospective Study:
Fifty nine (59) viral cultured nasal wash specimens from a teaching university/medical center were tested. Performance versus viral cell culture was calculated.
Prospective Study:
A multi-center prospective study evaluated 191 nasal wash specimens from patients with RSV-like symptoms. Performance versus viral cell culture was calculated.

Nasopharyngeal Swab - Clinical Sensitivity and Specificity:
A multi-center prospective study evaluated 179 nasopharyngeal swab specimens from patients with RSV-like symptoms. Performance versus DFA/viral cell culture was calculated.

Interfering Substances:
17 of 18 tested substances did not cross-react or interfere with the Binax NOW® test detection of RSV. Palivisumab was found to interfere with the detection of RSV. (No specific substances or results for the 17 that did not interfere are provided).

Reproducibility (as reported in original 510(k) K021687):
A blind study was conducted at 3 separate sites using coded specimens (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 support the assigned expiry dating.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found - The tables showing these metrics are unreadable.

Predicate Device(s)

BD Directigen™ EZ RSV Test, 510(k) #K022133

Reference Device(s)

BD RSV Test (K882629)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

OCT 2 1 2003

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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 Street
Portland, Maine 04103
(207) 772-3988 (Office)
(207) 871-5751 (FAX) |
|----------------------|------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Pamela S. Angell
pangell@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 21
CFR 866.3480) |
| PREDICATE DEVICE: | BD Directigen™ EZ RSV Test, 510(k) #K022133 |

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.

INTENDED USE:

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.

1

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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Prospective Srudy:

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

5

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
--------	---------

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

(Optional Format 1-2-96)