# K980354: Cryptosporidium Test

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: May 18, 1998 after 109 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) Microscopy (conventional staining methods): named in the summary without a submission number
- (no number) Alexon ProSpecT Cryptosporidium Microplate Assay: named in the summary without a submission number

## Indications for use
The Cryptosporidium TEST is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of Cryptosporidium gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K980354
Methodology: https://510kreport.com/methodology