# K062546: Immunocard Stat! Ehec, Model 751630

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Feb 14, 2007 after 168 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: 1 generation back to K953362 (1995). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 1.

## Most influential descendants
- K121364: Shiga Toxin Quik Chek (2012), 1 descendant of its own
- K222829: Curian® Shiga Toxin (2023), 0 descendants of its own
- K121411: Shiga Toxin Chek (2012), 0 descendants of its own

## Indications for use
Immunoohromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coil in cultures derived from clinical stool specimens. ImmunoCard STATI EHEC is used in conjunction with the patients clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. co/i (EHEC) infections.

Source page: https://510kreport.com/device/K062546
Methodology: https://510kreport.com/methodology