# K991697: Uni-Gold H. Pylori

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech, Plc
- Decided: Dec 21, 1999 after 217 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- 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) Quidel QuickVue One-Step H. pylori Test: named in the summary without a submission number

## Indications for use
The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in-vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.

Source page: https://510kreport.com/device/K991697
Methodology: https://510kreport.com/methodology