# K052932: Cryptosporidium II

- Pathway: 510(k) (Special)
- Applicant: Techlab, Inc.
- Decided: Nov 4, 2005 after 16 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103673: Giardia/ Cryptosporidium Quik Chek (2011), 0 descendants of its own

## Indications for use
The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection.

Source page: https://510kreport.com/device/K052932
Methodology: https://510kreport.com/methodology