# K053335: Premier Platinum Hpsa Plus, Models 601396, 601480

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Mar 10, 2006 after 99 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 K980076 (1998). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980076: Premier Platinum Hpsa, Meridian Diagnostics, Inc. (1998) Summary page 1.
- K983255: Modification to: Premier Platinum Hpsa, Meridian Diagnostics, Inc. (1998) Summary page 1.

## Most influential descendants
- K182559: PREMIER Platinum HpSA PLUS (2018), 3 descendants of its own
- K232892: Hp Detect™ Stool Antigen ELISA (2023), 0 descendants of its own
- K230901: Premier HpSA Flex (619096) (2023), 0 descendants of its own
- K192817: Curian HpSA, Curian Analyzer (2020), 0 descendants of its own
- K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (2018), 0 descendants of its own

## Indications for use
The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylor antigens in human stool. Test results are intended to aid in the diagnosis of H.pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Source page: https://510kreport.com/device/K053335
Methodology: https://510kreport.com/methodology