# K991820: Helicobacter Pylori Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)for the Detection of Igg Antibodi

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Aug 12, 1999 after 77 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 pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K991820
Methodology: https://510kreport.com/methodology