# K020920: Cozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone

- Pathway: 510(k) (Traditional)
- Applicant: Cozart Bioscience, Ltd.
- Decided: Nov 5, 2002 after 229 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K971961: RapidOne Opiates Test. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K992325: RapidOne Methadone Test. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Cozart RapiScan Oral Fluid Drug Test System - Opiates and Methadone is intended for Point of Care testing in a number of settings such as prescription workplace, drug dependency clinics. and criminal justice. It provides qualitative screening results for opiates and methadone in human oral fluid at a cut-off concentration equivalent to 40nglmL and 30nglmL respectively in neat oral fluid. The cozart collection system involves a 1.3 dilution of the oral fluid sample, this dilution factor is corrected for in the Cozart RapiScan Drug Test and therefore the remainder of this document will refer to the cut-offs as 13ng/mL for opiates and IOng/ml for methadone. This kit has to be used in conjunction with the Cozart RapiScan instrument. Please refer to the sampling and testing procedures in the instructions for use leaflet. This assay i s for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied t o 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. It is the responsibility of those organisations required to follow department of transportation (DOT) or the Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing guidelines to determine that this product satisfies the criteria for workplace testing established under DOT and SAMHSA.

Source page: https://510kreport.com/device/K020920
Methodology: https://510kreport.com/methodology