# K982711: Premier Giardia

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Nov 25, 1998 after 113 days
- Product code: MHI (Giardia Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Alexon ProspecT Giardia Microplate Assay: named in the summary without a submission number

## Indications for use
The Premier Giardia enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Giardia antigens in human stool. Test results are intended to aid in the diagnosis of Giardia infection (giardiasis).

Source page: https://510kreport.com/device/K982711
Methodology: https://510kreport.com/methodology