(146 days)
Not Found
None
No
The summary describes a visual test for antigen detection and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as information typically associated with AI/ML development like training/test sets and performance metrics like AUC.
No
Explanation: This device is a diagnostic test for detecting bacterial antigens and does not provide therapy or treatment.
Yes
The device is described as a "visual test for the presumptive qualitative detection of group A streptococcal antigen," which directly indicates its use in identifying a disease presence, fitting the definition of a diagnostic device.
No
The device is described as a "visual test" for detecting an antigen from a throat swab specimen. This strongly implies a physical test kit or assay, not a software-only device. The lack of any mention of software, algorithms, or digital processing further supports this conclusion.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "presumptive qualitative detection of group A streptococcal antigen from throat swab specimens." This involves testing a sample taken from the human body (throat swab) in vitro (outside the body) to diagnose or provide information about a medical condition (presence of group A streptococcal antigen).
- Nature of the Test: It's a "visual test" for detecting an "antigen," which is a biological marker. This aligns with the typical function of IVD tests.
- Specimen Type: It uses "throat swab specimens," which are biological samples.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SASTM Strep A test clearly fits this description.
N/A
Intended Use / Indications for 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.
Product codes
GTY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
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
2
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 _____________________________________________________________________________________________________________________________________________________________