# K012588: Oxoid Pylori Test Kit, Model DR0130M

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid, Ltd.
- Decided: Dec 10, 2001 after 122 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
Oxoid Pylori Test Kit is a rapid latex agglutination test for the qualitative detection of Helicobacter pylori total antibodies in serum as an aid in the diagnosis of infections by H. pylori. The product is intended for use to test patients 18 years and older, with symptoms of gastro-intestinal disorders.

Source page: https://510kreport.com/device/K012588
Methodology: https://510kreport.com/methodology