# K032222: Immunocardstat Hpsa

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Dec 5, 2003 after 137 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: 1 generation back to K983255 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983255: Modification to: Premier Platinum Hpsa, Meridian Diagnostics, Inc. (1998) Summary page 1.

## Most influential descendants
- K183573: Vstrip H. pylori Antigen Rapid Test (2019), 0 descendants of its own
- K181379: H. Pylori Quik Chek (2018), 0 descendants of its own

## Indications for use
ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen (HpSA) in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylon infection and to demonstrate loss of H. pylon stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy.

Source page: https://510kreport.com/device/K032222
Methodology: https://510kreport.com/methodology