# K110745: Helicobacter Pylori Elisa Igg Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Diagnostics
- Decided: Mar 2, 2012 after 351 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
Longest line of descent: 1 generation back to K973508 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973508: Pylori Detect Igg, Micro Detect, Inc. (1998) Summary page 1.

## Indications for use
The Helicobacterpylori (H.pyloni) ELISA IgG test kit is intended for the qualitative detection of IgG antibodies to H. pylori in human serum in the adult population. This test is intended to aid in the diagnosis of H. pylori in patients suspected of having H. pylori infection, and in patients with gastrointestinal symptoms, and is to be used in conjunction with clinical findings.

Source page: https://510kreport.com/device/K110745
Methodology: https://510kreport.com/methodology