SAS STREPALERT

K013379 · Sa Scientific, Inc. · GTY · Dec 12, 2001 · Microbiology

Device Facts

• Record ID: K013379
• Device Name: SAS STREPALERT
• Applicant: Sa Scientific, Inc.
• Product Code: GTY · Microbiology
• Decision Date: Dec 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Intended Use

SASTM StrepAlert is a visual test for the qualitative detection of Group A Streptococcus antigen in throat swab specimens. The test is for professional use.

Device Story

SAS™ StrepAlert is a lateral flow immunoassay for the qualitative detection of Group A Streptococcus antigen in throat swab specimens. The device is intended for professional use in clinical settings. It utilizes an immunochromatographic principle where the sample is applied to a test device; the presence of Group A Strep antigen results in a visible line. The test provides rapid results to assist healthcare providers in diagnosing Group A Streptococcal pharyngitis, facilitating timely clinical decision-making regarding antibiotic therapy. The device is a standalone, manual diagnostic test.

Clinical Evidence

No clinical data provided; device is a standard lateral flow immunoassay.

Technological Characteristics

Lateral flow immunoassay; visual qualitative detection; manual test format; no electronic components or software.

Indications for Use

Indicated for the qualitative detection of Group A Streptococcus antigen in throat swab specimens. For professional use only.

Regulatory Classification

Identification

Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

DEC 1 2 2001

k013379 Re:

Trade/Device Name: SAS™ StrepAlert Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. Serological reagents Regulatory Class: Class I Product Code: GTY Dated: October 11, 2001 Received: October 12, 2001

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 for association 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notheation. The I Dri Imaling of raction for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 II you desire opening an in vitro diagnostic devices), please contact the Office of Compliance at additionally 007.10 for questions on the promotion and advertising of your device, [phone]. Frashions of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mioritiation on your responsible and Consumer Assistance at its toll-free number [phone] or Manufacturers Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

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

Establishment Reg. No.: 1645225

501(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name:

SASTM StrepAlert

Indications for Use:

SASTM StrepAlert is a visual test for the qualitative detection SAS - Burephiere is a virus in throat swab specimens. The test is for professional use.

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Leedula Poole (Per 21 CFR 801.109) | |
|-----------------------------------------|------------------------------------|------------------|
| (Division Sign-Off) | | |
| Division of Clinical Laboratory Devices | | |
| 510(k) Number | K013379 | |
| Prescription Use | or | Over-the-Counter |