SAS STREPALERT

K023270 · Sa Scientific, Inc. · GTY · Oct 17, 2002 · Microbiology

Device Facts

• Record ID: K023270
• Device Name: SAS STREPALERT
• Applicant: Sa Scientific, Inc.
• Product Code: GTY · Microbiology
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

SASTM StrepAlert is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.

Device Story

SAS™ StrepAlert is a rapid, qualitative, visual diagnostic test for detecting group A streptococcal antigen in throat swab specimens. Designed for professional clinical use, the device utilizes an immunoassay format to provide presumptive results. The healthcare provider collects a throat swab, processes the sample, and applies it to the test device. The presence of group A streptococcal antigen is indicated by a visual signal on the test strip. This rapid result assists clinicians in the immediate identification of group A streptococcal infections, facilitating timely clinical decision-making regarding patient treatment and management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rapid visual immunoassay for antigen detection. Form factor is a test device for throat swab specimens. Professional use only.

Indications for Use

Indicated for professional use for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 1 7 2002

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

Re: k023270

> 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: September 30, 2002 Received: October 1, 2002

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 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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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 predicate device results in a classification 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office 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 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 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

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

Establishment Reg. No.: 1645225

501(k) Number: K023 270

Device Name:

SASTM StrepAlert

Indications for Use:

SASTM StrepAlert is a rapid visual test for the presumptive, qualitative 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, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Freddie Poole

(Division Sian-Off Division of Clinica 510(k) Number

Prescription Use Use U

Or

Over-the-Counter