# K030234: Cozart Eia Cocaine Oral Fliud Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cozart Bioscience, Ltd.
- Decided: Apr 28, 2003 after 95 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
Longest line of descent: 2 generations back to K924446 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981341: STC Opiates Micro-Plate Eia (Orasure Application), OraSure Technologies, Inc. (1998) Summary page 1.

## Indications for use
The Cozart EIA Cocaine Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for cocaine and metabolites in human oral fluid at a cutoff concentration of 10nglml. This is equal to 30ng/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. 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 ChromatographyIMass Spectrometry (GCIMS) is the preferred confirmatory method.

Source page: https://510kreport.com/device/K030234
Methodology: https://510kreport.com/methodology