# K961508: Immunocard H. Pylori

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Jan 21, 1997 after 277 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) ImmunoCard Helicobacter pylori: named in the summary without a submission number

## Indications for use
The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma and whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. ImmunoCard H. pylori may be performed by clinical laboratories or in physician's offices.

Source page: https://510kreport.com/device/K961508
Methodology: https://510kreport.com/methodology