# K051929: Giardia/Cryptosporidium Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Nov 17, 2005 after 127 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 K912408 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955157: Prospect Giardia/Cryptosporidium Microplate Assay, Alexon Biomedical, Inc. (1996) Summary page 1.
- K912408: Merifluor-Cryptosporidium/Giardia, Meridian Diagnostics, Inc. (1991) Summary page 1.

## Most influential descendants
- K171078: Tri-Combo Parasite Screen (2017), 0 descendants of its own

## Indications for use
The GIARDIA/CRYPTOSPORIDIUM CHEK TM test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.

Source page: https://510kreport.com/device/K051929
Methodology: https://510kreport.com/methodology