# K133343: Wondfo Rapid Strep a Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Jan 31, 2014 after 93 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
Longest line of descent: 2 generations back to K971349 (1997). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K040708: Status First Strep a, Princeton BioMeditech Corp. (2004) Summary page 1.

## Most influential descendants
- 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
The Wondfo Strep A Rapid Test is a chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens from symptomatic patients to aid in the diagnosis of Group A Streptococcal Infection. All negative test results should be confirmed by bacterial Culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use, only. For in vitro diagnostic use For prescription Use only

Source page: https://510kreport.com/device/K133343
Methodology: https://510kreport.com/methodology