# K980076: Premier Platinum Hpsa

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: May 12, 1998 after 124 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices 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) CLOtest, rapid urease test for biopsy specimens: named in the summary without a submission number

## Most influential descendants
- K053335: Premier Platinum Hpsa Plus, Models 601396, 601480 (2006), 6 descendants of its own
- 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

## Indications for use
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection in adult symptomatic patients.

Source page: https://510kreport.com/device/K980076
Methodology: https://510kreport.com/methodology