(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.
§ 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.