# K061889: Biostar Oia Shigatox

- Pathway: 510(k) (Traditional)
- Applicant: Inverness Medical-Biostar, Inc.
- Decided: Dec 12, 2006 after 162 days
- Product code: GMZ (Antigens, All Types, Escherichia Coli)
- Device class: 1
- Regulation: 21 CFR 866.3255
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953362 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- K980507: Prospect Shiga Toxin Microplate Assay, Alexon - Trend, Inc. (1998) Summary page 1.

## Most influential descendants
- K071799: Modification to Biostar Oia Shigatox (2007), 0 descendants of its own

## Recalls of this device
- Sep 27, 2016 · Class II · Z-0965-2017: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

## 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, and 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/K061889
Methodology: https://510kreport.com/methodology