# K982764: Premier Cryptosporidium

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Dec 3, 1998 after 119 days
- Product code: MHJ (Cryptosporidium 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) ProSpecT Cryptosporidium Microplate Assay: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K982764
Methodology: https://510kreport.com/methodology