SAS RSV TEST

K022845 · Sa Scientific, Inc. · GQG · Jan 29, 2003 · Microbiology

Device Facts

• Record ID: K022845
• Device Name: SAS RSV TEST
• Applicant: Sa Scientific, Inc.
• Product Code: GQG · Microbiology
• Decision Date: Jan 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3480
• Device Class: Class 1

Indications for Use

SAS™ RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens. The test is for professional use.

Device Story

SAS™ RSV Test is a rapid, visual, qualitative immunoassay for detecting RSV antigen in nasopharyngeal specimens. Designed for professional clinical laboratory use; provides rapid results to assist in diagnosing RSV infections. Operates via lateral flow or similar immunoassay principle; visual interpretation of test results by healthcare professionals. Facilitates timely clinical decision-making for patient management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Rapid, visual, qualitative immunoassay for RSV antigen detection. Professional use device.

Indications for Use

Indicated for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal specimens. For professional use only.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol resembling an abstract human figure or a caduceus, composed of three curved lines.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

JAN 2 9 2003

Mr. Ricardo R. Martinez Director of Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240

Re: k022845

Trade/Device Name: SASTM RSV Test Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory Syncytial Virus Serological Reagents. Regulatory Class: Class I Product Code: GQG Dated: January 13, 2003 Received: January 19, 2003

Dear Mr. Martinez:

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 reguirements 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 (OS) 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 vours.

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

Applicant: SA Scientific, Inc. 4919 Golden Quail San Antonio, TX. 78240 Ph: [phone] Fax: [phone]

Establishment Reg. No.: 1645225

501(k) Number: K023845

Device Name:

SAS™ RSV Test

Indications for Use:

SAS™ RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens.

The test is for professional use.

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109

(21 CFR 801.109) Freddie Lu. Poole

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022845

Prescription Use
✓

or

Over-the-Counter