# K012411: HP-ONE

- Pathway: 510(k) (Traditional)
- Applicant: Gi Supply
- Decided: Sep 25, 2001 after 57 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. The FDA summary names its predicate without a number.
- (no number) HP-Fast: named in the summary without a submission number

## Indications for use
HP-ONE is for in-vitro diagnostic use only. It is intended to detect the urease enzyme of Helicobacter pylori and provide a presumptive diagnosis of H. pylori gastritis.

Source page: https://510kreport.com/device/K012411
Methodology: https://510kreport.com/methodology