# K980782: Stat-Simple Pylori

- Pathway: 510(k) (Traditional)
- Applicant: Saliva Diagnostic Systems, Inc.
- Decided: Aug 5, 1998 after 156 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
Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative detection of circulating IgG antibody to Helicobacter pylori in whole blood or serum. The blood specimen for the test is obtained by “finger-prick” using a lancet designed for that purpose. This test is intended for use in the clinical laboratory or the physician’s office. The test is intended for use as an aid to diagnosis of H. pylori infection in persons with gastrointestinal symptoms consistent with diseases related to H. pylori infection (1). FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K980782
Methodology: https://510kreport.com/methodology