# K993401: Dryspot E.Coli 0157 Kit

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid, Ltd.
- Decided: Feb 28, 2000 after 143 days
- Product code: GNA (Antisera, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Oxoid Dryspot E.coli 0157 test is a latex agglutination test for the identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. The test is not indicated for direct testing of faecal specimens.

Source page: https://510kreport.com/device/K993401
Methodology: https://510kreport.com/methodology