# K972981: Shield Helico-G2 Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Shield Diagnostics, Ltd.
- Decided: Mar 17, 1998 after 218 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 Shield Helico G2 kit is a qualitative indirect enzyme immunoassay for the detection of the IgG class of antibodies for Helicobacter pylori (H pylori) in human serum or plasma (EDTA or Heparin ). The test is intended as an aid in the diagnosis of H pylori infection in adults and is not definitive in isolation. Antibodies represent one parameter in a multi-criteria diagnostic process.

Source page: https://510kreport.com/device/K972981
Methodology: https://510kreport.com/methodology