# K052708: Pylo-Plus

- Pathway: 510(k) (Traditional)
- Applicant: Arj Medical, Inc.
- Decided: May 1, 2006 after 214 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.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has 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.

## Most influential descendants
- K101234: Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody (2011), 0 descendants of its own

## Indications for use
Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pyloni in symptomatic patients. ARJI Medical's Pylo-Plus Rapid Urease Tests are for single use by medical and laboratory personnel. Pylo-Plus is intended for use in screening at-risk patients to assist diagnosis in the field of Gastroenterology.

Source page: https://510kreport.com/device/K052708
Methodology: https://510kreport.com/methodology