# K033067: Pylori Igg

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech USA
- Decided: Nov 26, 2003 after 58 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) Biowhittaker Pylori Stat: named in the summary without a submission number

## Indications for use
The Trinity Biotech CaptiaTMH. pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori, as an aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease, and is not intended for use in asymptomatic patients.

Source page: https://510kreport.com/device/K033067
Methodology: https://510kreport.com/methodology