(146 days)
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.
Not Found
The provided text is an FDA 510(k) clearance letter for the SAS™ Strep A Test. It establishes substantial equivalence to a predicate device and outlines regulatory responsibilities but does not contain the acceptance criteria or a study describing the device's performance against such criteria.
Therefore, I cannot provide the requested information from the given text.
To address your request, I would need access to the actual 510(k) summary or the pivotal study report that was submitted to the FDA for this device. These documents typically contain the detailed performance data and acceptance criteria.
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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 (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 milliation on your roop at its toll-free number (800) 638-2041 or (301) 443-6597 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: (210) 699-8800 Fax: (210) 699-6545
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
ਾ
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.