# K222829: Curian® Shiga Toxin

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Apr 17, 2023 after 210 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: 3 generations back to K953362 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121364: Shiga Toxin Quik Chek, Techlab Inc., Corporate Research Center (2012) Summary page 5.

## Indications for use
The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient’s clinical symptoms and history.

Source page: https://510kreport.com/device/K222829
Methodology: https://510kreport.com/methodology