# K071799: Modification to Biostar Oia Shigatox

- Pathway: 510(k) (Traditional)
- Applicant: Iverness Medical Professional Diagnostics
- Decided: Oct 2, 2007 after 92 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
Longest line of descent: 2 generations back to K953362 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061889: Biostar Oia Shigatox, Inverness Medical-Biostar, Inc. (2006) Summary page 1.

## Indications for use
The BioStar® OIA® SHIGATOX assay is an Optical Immunoassay (OIA) test for the qualitative, rapid detection of the presence of Shiga Toxins in human diarrheal fecal specimens, broth cultures, fecal specimens in Cary Blair Transport Media, or swab sampling of colonies from a culture plate. This test is intended for in vitro diagnostic use as an aid in the diagnosis of infection by Shiga Toxin-producing Escherichia coli (STEC) both 0157 and all non - 0157 Shiga toxin producing strains.

Source page: https://510kreport.com/device/K071799
Methodology: https://510kreport.com/methodology