# K972481: Auto-Lyte Cotinine Eia

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Oct 21, 1997 after 111 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; 3 cite 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
- K062565: Status DS Nicotine, Accusign Nicotine, Biosign Nicotine (2007), 0 descendants of its own
- K030649: Dri Cotinine Eia Assay (2003), 0 descendants of its own
- K021944: Cozart Eia Cotinine Urine Kit (2003), 0 descendants of its own

## Indications for use
The STC Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K972481
Methodology: https://510kreport.com/methodology