Cleared Traditional

K020920 - COZART RAPISCAN ORAL FLUID DRUG TEST - ...

K020920 is the FDA 510(k) clearance for COZART RAPISCAN ORAL FLUID DRUG TEST - ... by Cozart Bioscience , Ltd.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K020920 · Cozart Bioscience , Ltd. · Toxicology device
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Nov 2002
Decision
229d
Days
Class 2
Risk

K020920 is an FDA 510(k) clearance for the COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Cozart Bioscience , Ltd. (Oxfordshire Ox14 4ru, GB). The FDA issued a Cleared decision on November 5, 2002 after a review of 229 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cozart Bioscience , Ltd. devices

Submission Details

510(k) Number K020920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2002
Decision Date November 05, 2002
Days to Decision 229 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 87d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 137
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K020920.
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · ACON Laboratories, Inc. · May 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
K033047 · ACON Laboratories, Inc. · Feb 2004
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · Beckman Coulter, Inc. · Apr 2003
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · Lin-Zhi International, Inc. · Jun 2002
OPIATES
K013314 · Abbott Laboratories · Mar 2002
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · Roche Diagnostics Corp. · Dec 2001