# K981396: Pyloriprobe

- Pathway: 510(k) (Traditional)
- Applicant: Amdl, Inc.
- Decided: Jul 30, 1998 after 104 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
PyloriProbe™ is an ELISA test intended for the qualitative detection of serum IgG antibodies to H. pylori as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test is not to be used with asymptomatic patients. The tests are carried out in clinical laboratories by laboratory technologists / technicians and the test results are measured in a microtiter plate reader instrument.

Source page: https://510kreport.com/device/K981396
Methodology: https://510kreport.com/methodology