# K953362: Premier Ehec

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Nov 14, 1995 after 120 days
- Product code: GNA (Antisera, All Types, Escherichia Coli)
- Device class: 1
- Regulation: 21 CFR 866.3255
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062546: Immunocard Stat! Ehec, Model 751630 (2007), 3 descendants of its own
- K121364: Shiga Toxin Quik Chek (2012), 1 descendant of its own
- K061889: Biostar Oia Shigatox (2006), 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

## Recalls of this device
- Nov 8, 2016 · Class II · Z-1033-2017: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
- Oct 10, 2011 · Not classified · Z-0203-2012: Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, 

Source page: https://510kreport.com/device/K953362
Methodology: https://510kreport.com/methodology