# K982373: Uni-Gold Strep a Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech, Plc
- Decided: Feb 11, 1999 after 219 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TestPack® +Plus Strep A: named in the summary without a submission number

## Indications for use
The Trinity Biotech Uni-Gold™ Strep A Test Kit is a rapid immunoassay for the qualitative detection of Streptococcal A antigen from throat swabs, or the confirmation of beta-hemolytic colonies obtained from blood agar plates. It is intended for use in hospital laboratories and physicians’ offices as an aid in the diagnosis of Group A Streptococcal pharyngitis.

Source page: https://510kreport.com/device/K982373
Methodology: https://510kreport.com/methodology