# K983255: Modification to: Premier Platinum Hpsa

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Dec 17, 1998 after 93 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 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) Meretek UBT: 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
- K032222: Immunocardstat Hpsa (2003), 2 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

## Recalls of this device
- Dec 26, 2002 · Not classified · Z-0465-03: Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.

## 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, and to monitor response during and post-therapy in adult 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/K983255
Methodology: https://510kreport.com/methodology