(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.
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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.
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§ 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.