# K103673: Giardia/ Cryptosporidium Quik Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab Inc., Corporate Research Center
- Decided: Aug 18, 2011 after 245 days
- Product code: MHI (Giardia 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912408: Merifluor-Cryptosporidium/Giardia, Meridian Diagnostics, Inc. (1991) Summary page 2.
- K033274: Giardia II, Techlab, Inc. (2003) Summary page 2.
- K052932: Cryptosporidium II, Techlab, Inc. (2005) Summary page 2.

## Indications for use
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.

Source page: https://510kreport.com/device/K103673
Methodology: https://510kreport.com/methodology