# K041238: Helicobacter Pylori Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Biohit Plc
- Decided: Dec 13, 2004 after 216 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 K000463 (2000). 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)
- K000463: Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg, Diagnostic Products Corp. (2000) Summary page 1.

## Indications for use
The Helicobacter pylori IgG ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human IgG class antibodies to Helicobacter pylori in serum and in EDTA or heparin-treated plasma. The test is intended to aid in the diagnosis of Helicobacter pylori infection in adult patients with clinical symptoms of gastritis. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K041238
Methodology: https://510kreport.com/methodology