(61 days)
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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the SAS™ StrepAlert device. This document confirms the device's substantial equivalence to a legally marketed predicate device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a study report or a more extensive submission document.
Therefore, I cannot provide the requested table of acceptance criteria and device performance, or details about the study design, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided FDA clearance letter.
The letter primarily focuses on:
- Device Name: SAS™ StrepAlert
- Regulation Number: 21 CFR 866.3740 (Streptococcus spp. Serological reagents)
- Regulatory Class: Class I
- Product Code: GTY
- Indications for Use: "SASTM StrepAlert is a visual test for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. The test is for professional use."
- 510(k) Number: K013379
To obtain the detailed information regarding acceptance criteria and study results, one would typically need to refer to the original 510(k) submission document or a summary thereof, which often includes a "Summary of Safety and Effectiveness Data" that details the studies performed to demonstrate substantial equivalence. This information is not found within the provided FDA clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, with three curved lines representing the wings and body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
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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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, (201) 594-1566. Frashions of Compliance at (301) 594-4639. 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 (800) 638-2041 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: (210) 699-8800 Fax: (210) 6996545
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 |
§ 866.3740
Streptococcus spp. serological reagents.(a)
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 identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.