# K121411: Shiga Toxin Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab Inc., Corporate Research Center
- Decided: Oct 2, 2012 after 144 days
- Product code: GMZ (Antigens, All Types, Escherichia Coli)
- Device class: 1
- Regulation: 21 CFR 866.3255
- 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 K953362 (1995). 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)
- K953362: Premier Ehec, Meridian Diagnostics, Inc. (1995) Summary page 3.
- K062546: Immunocard Stat! Ehec, Model 751630, Meridian Bioscience, Inc. (2007) Summary page 3.
- K980507: Prospect Shiga Toxin Microplate Assay, Alexon - Trend, Inc. (1998) Summary page 3.

## Indications for use
The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coi (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.

Source page: https://510kreport.com/device/K121411
Methodology: https://510kreport.com/methodology