# K021944: Cozart Eia Cotinine Urine Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cozart Bioscience, Ltd.
- Decided: May 14, 2003 after 335 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
Longest line of descent: 1 generation back to K972481 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972481: Auto-Lyte Cotinine Eia, OraSure Technologies, Inc. (1997) Summary page 1.

## Indications for use
The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/mL. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.

Source page: https://510kreport.com/device/K021944
Methodology: https://510kreport.com/methodology