# K971349: Biosign Strep a - Direct Strep a Antigen Test

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jul 7, 1997 after 88 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040708: Status First Strep a (2004), 3 descendants of its own
- K133343: Wondfo Rapid Strep a Test (2014), 2 descendants of its own
- K260342: AllTest Strep A Rapid Test (2026), 0 descendants of its own
- K212623: Healgen Strep A Rapid Test Strip (Throat Swab) (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K971349
Methodology: https://510kreport.com/methodology