# K955755: Trend Cryptosporidium Detection Test Systems

- Pathway: 510(k) (Traditional)
- Applicant: Trend Scientific, Inc.
- Decided: Jul 11, 1996 after 204 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 no predicate by number.

## Indications for use
The intended use of the device is for the qualitative determination of Cryptosporidium antigen in feces. The ELISA test kit is indicated for use with fecal specimens from patient’s with diarrhea to aid in the detection of Cryptosporidium gastrointestinal infection.

Source page: https://510kreport.com/device/K955755
Methodology: https://510kreport.com/methodology