SAS STREP A TEST

K993456 · Sa Scientific, Inc. · GTY · Mar 7, 2000 · Microbiology

Device Facts

• Record ID: K993456
• Device Name: SAS STREP A TEST
• Applicant: Sa Scientific, Inc.
• Product Code: GTY · Microbiology
• Decision Date: Mar 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Intended Use

SASTM Strep A is a visual test for the presumplive qualitative detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.

Device Story

SAS™ Strep A Test is a lateral flow immunoassay for qualitative detection of Group A streptococcal antigen in throat swab specimens. Device used in clinical laboratory settings by healthcare professionals. Input: throat swab specimen. Principle: immunochromatographic assay; antigen-antibody binding produces visual color change on test strip. Output: visual qualitative result (positive/negative). Assists clinicians in rapid diagnosis of Group A streptococcal pharyngitis; facilitates timely antibiotic treatment decisions.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Lateral flow immunochromatographic assay; visual qualitative detection; manual test format; professional use.

Indications for Use

Indicated for the presumptive qualitative detection of group A streptococcal antigen from throat swab specimens in patients suspected of having a Group A Strep infection. 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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## MAR - 7 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Harbi A. Shadfan, Ph.D. President SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240

Re: K993456 Trade Name: SAS™ Strep A Test Regulatory Class: I Product Code: GTY Dated: January 24, 2000 Received: January 28, 2000

Dear Dr. Shadfan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate ass butter in the time as a 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you w togin manomial equivalence of your device to a legally marketed nonthcanni. The I D71 midnig of baction 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 IT you desire specific acrited in your asic devices), please contact the Office of Compliance at additionally 607.10 for millionally, for questions on the proniotion and advertising of your device, ( 2017 591 1566: Tradition f 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 milliation on your roop at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: SASTM Strep A Test

SASTM Strep A is a visual test for the presumplive qualitative Indications for Use: detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.

(Please do not write below this line)

Concurrence of CDRH, Ollice of Device Evaluation (ODE)

(Per 2 CFR 801.109)
Woody Dubres

510/k) Number

Prescription Use X

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Over-the-Counter _____________________________________________________________________________________________________________________________________________________________