(88 days)
Immunoassay for the qualitative detection of Group A Streptococcal antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
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This document is a 510(k) clearance letter from the FDA for the BioSign Strep A - Direct Strep A Antigen Test. It confirms that the device is substantially equivalent to other devices marketed before May 28, 1976. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.
The provided text only includes:
- Device Name: BioSign™ Strep A
- Indications For Use: Immunoassay for the qualitative detection of Group A antigen directly from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
- Regulatory Class: I
- Product Code: GTY
- 510(k) Number: K971349
To answer your questions, I would need access to the actual 510(k) submission (K971349), which would detail the clinical studies and data used to support the substantial equivalence claim. This type of information is typically found in the "Establishment of Substantial Equivalence" or "Performance Data" sections of a 510(k) submission, which are not present in 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.