# K971537: Pyloriset Eia-G (68926)

- Pathway: 510(k) (Traditional)
- Applicant: Orion Diagnostica, Div. Orion Corp.
- Decided: Jun 27, 1997 after 60 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022356: Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay (2002), 0 descendants of its own

## Indications for use
Pyloriset EIA-G is a qualitative enzyme immunoassay for the detection of Helicobacter pylori specific IgG antibodies in human serum as an aid in diagnosing infection by H. pylori. The product is intended for use to test patients with symptoms of gastrointestinal disorders.

Source page: https://510kreport.com/device/K971537
Methodology: https://510kreport.com/methodology