# K024339: Cozart Eia Opiates Oral Fluid Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cozart Bioscience, Ltd.
- Decided: Apr 7, 2003 after 101 days
- Product code: DIG (Cholinesterase Test Paper)
- Device class: 1
- Regulation: 21 CFR 862.3240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Cozart EIA Opiates 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 Opiates in human oral fluid at a cutoff concentration of IOnglml. This is equal to 3Ong/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 ChromatographylMass Spectrometry (GCIMS) is the preferred confirmatory method.

Source page: https://510kreport.com/device/K024339
Methodology: https://510kreport.com/methodology