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Cozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone

by Cozart Bioscience, Ltd.

510(k) K020920

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020920 Date5 Nov 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DJG
FDA applicant
Cozart Bioscience , Ltd.
Device Class
Class II
Regulation
21 CFR Part 862.3650
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cozart Rapiscan Oral Fluid Drug Test is an enzyme immunoassay used for the qualitative screening of opiates and methadone in human oral fluid. It functions as a point-of-care screening tool designed to detect these substances at cut-off concentrations of 40ng/mL for opiates and 30ng/mL for methadone.

This device is intended for use in settings such as workplace testing, drug dependency clinics, and criminal justice environments. It has received FDA 510(k) clearance under K020920 and is classified under clinical toxicology.

Other devices from Cozart Bioscience, Ltd.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Cozart Rapiscan Oral Fluid Drug Test?

    This device is an enzyme immunoassay designed for the qualitative screening of opiates and methadone in human oral fluid. It is intended for use as a point-of-care screening tool in professional environments, including workplace testing, drug dependency clinics, and criminal justice settings.

  • What are the detection cut-off concentrations for this test?

    The test is calibrated to detect opiates at a cut-off concentration of 40ng/mL and methadone at a cut-off concentration of 30ng/mL in oral fluid samples.

  • Has this device received regulatory clearance?

    Yes, the Cozart Rapiscan Oral Fluid Drug Test has received FDA 510(k) clearance under the submission number K020920.