# K974234: Micro-Plate Cotinine Eia

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: May 14, 1998 after 183 days
- Product code: MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites)
- Device class: 1
- Regulation: 21 CFR 862.3220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033601: Labone Micro-Plate Cotinine Eia (2004), 2 descendants of its own
- K223162: Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (2023), 1 descendant of its own
- K252523: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K974234
Methodology: https://510kreport.com/methodology