# K031059: Ivd Cryptosporidium Antigen Detection Assay, Model CP-96

- Pathway: 510(k) (Traditional)
- Applicant: Ivd Research, Inc.
- Decided: Jul 10, 2003 after 104 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
Longest line of descent: 1 generation back to K955345 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955345: LMD Cryptosporidium Antigen Detection, Lmd Laboratories (1996) Summary page 1.

## Indications for use
This microwell enzyme linked immunoabsorbant assay (ELLISA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium antigen in human feces using peroxidase as the enzyme. The assay may be read visually or with an ELISA reader. This IVD assay is intended to be used with stools that are fresh, frozen or preserved in 10% formalin, iSAF or Medical Chemical Corporation's (MCC) Universal fixative. Concentrated samples cannot be used with this IVD.

Source page: https://510kreport.com/device/K031059
Methodology: https://510kreport.com/methodology