# K980821: Helicobacter Pylori Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jul 30, 1998 after 149 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Zeus Scientific, Inc. Helicobacter pylon IgG ELISA test System is intended for the qualitative detection of IgG antibody in symptomatic adult serum. It may or may not be indicated as an aid in the determination of serological status.

Source page: https://510kreport.com/device/K980821
Methodology: https://510kreport.com/methodology