# K973651: STC Cocaine Metabolite Micro-Plate Eia

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Jan 2, 1998 after 99 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K040198: Labone Cocaine Metabolite Micro-Plate Eia (2004), 0 descendants of its own

## Indications for use
The STC Cocaine Metabolite Micro-Plate EIA is intended for use in the qualitative determination of cocaine and cocaine metabolites in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K973651
Methodology: https://510kreport.com/methodology