# K980507: Prospect Shiga Toxin Microplate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Alexon - Trend, Inc.
- Decided: Apr 23, 1998 after 72 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices 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.

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

## Recalls of this device
- Jul 18, 2002 · Not classified · Z-1373-04: A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.

## Indications for use
The ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.

Source page: https://510kreport.com/device/K980507
Methodology: https://510kreport.com/methodology