# K183573: Vstrip H. pylori Antigen Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Panion & BF Biotech, Inc.
- Decided: Mar 14, 2019 after 83 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
Longest line of descent: 2 generations back to K983255 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032222: Immunocardstat Hpsa, Meridian Bioscience, Inc. (2003) Summary page 5.

## Indications for use
Vstrip® H.pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

Source page: https://510kreport.com/device/K183573
Methodology: https://510kreport.com/methodology