# K121565: Uni-Gold Cryptosporidium

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech
- Decided: Feb 8, 2013 after 255 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: 2 generations back to K983399 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031965: Xpect Cryptosporidium Lateral Flow Assay, Model 2451020, Remel, Inc. (2003) Summary page 2.

## Indications for use
Trinity Biotech Uni-GoldTM Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

Source page: https://510kreport.com/device/K121565
Methodology: https://510kreport.com/methodology