# K990263: Immunocard Stat! E. Coli O157:H7

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Aug 9, 1999 after 194 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) E. coli 0157 Elisa Stool Assay: named in the summary without a submission number

## Indications for use
The Immunocard STAT! STEC 0157 is a rapid test for the detection of antigens from shiga toxin producing E. coli 0157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

Source page: https://510kreport.com/device/K990263
Methodology: https://510kreport.com/methodology