BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK

K021687 · Binax, Inc. · GQG · Sep 13, 2002 · Microbiology

Device Facts

• Record ID: K021687
• Device Name: BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
• Applicant: Binax, Inc.
• Product Code: GQG · Microbiology
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3480
• Device Class: Class 1
• Attributes: Pediatric

Intended 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 specimens from symptomatic patients. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in neonatal and pediatric patients under the age of five. It is recommended that negative test results be confirmed by cell culture.

Device Story

Binax NOW® RSV Test is a rapid immunochromatographic assay; detects RSV fusion protein antigen in nasal wash specimens. Used in clinical settings for symptomatic neonatal and pediatric patients (<5 years). Principle of operation: lateral flow immunoassay; antigen-antibody binding produces visual result. Healthcare providers interpret visual test line to aid RSV infection diagnosis. Benefits: rapid identification of RSV to guide clinical management. Negative results require cell culture confirmation.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Rapid immunochromatographic assay (lateral flow). Qualitative detection of RSV fusion protein antigen. In vitro diagnostic use.

Indications for Use

Indicated for qualitative detection of RSV fusion protein antigen in nasal wash specimens from symptomatic neonatal and pediatric patients under age five. Negative results require confirmation by cell culture.

Regulatory Classification

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.

Submission Summary (Full Text)

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NOV 3 2003 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Anne Jepson Manager, Technical Support and Services Binax, Inc. 217 Read Street Portland, ME 04103

> k021687 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: GQG Dated: July 25, 2002 Received: July 26, 2002

Dear Ms. Jepson:

Re:

This letter corrects our substantially equivalent letter of September 13, 2002, regarding the Binax Now RSV Test. The Product Code has been corrected from GOG to GQG.

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 determina:i on 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).

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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 [phone]. 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 [phone] or [phone] 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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## INDICATIONS FOR USE FORM

510 (k) Number (if known): K021687

i

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 specimens from symptomatic patients. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in neonatal and pediatric patients under the age of five. It is recommended that negative test results be confirmed by cell culture.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Freddie W. Poole for PDR

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K021687 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div> ✓ </div> | OR | Over-The-Counter Use |
|----------------------|-----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)