Cleared Traditional

K021944 - COZART EIA COTININE URINE KIT

K021944 is an FDA 510(k) clearance for COZART EIA COTININE URINE KIT, manufactured by Cozart Bioscience , Ltd.. The device is a Class 1 Toxicology device with product code MKU cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K021944 · Cozart Bioscience , Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
335d
Days
Class 1
Risk

K021944 is an FDA 510(k) clearance for the COZART EIA COTININE URINE KIT. Classified as Enzyme Immunoassay, Nicotine And Nicotine Metabolites (product code MKU), Class I - General Controls.

Submitted by Cozart Bioscience , Ltd. (Oxfordshire Ox14 4ru, GB). The FDA issued a Cleared decision on May 14, 2003 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3220 - 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K021944

510(k) Number K021944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2002
Decision Date May 14, 2003
Days to Decision 335 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
248d slower than avg
Panel avg: 87d · This submission: 335d
Pathway characteristics
Predicate-based equivalence.

MKU Device Classification - Class 1, General Controls

Product Code MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Devices cleared under the same product code (MKU) and FDA review panel - the closest regulatory comparables to K021944.
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MICRO-PLATE COTININE EIA
K974234 · OraSure Technologies, Inc. · May 1998
AUTO-LYTE COTININE EIA
K972481 · OraSure Technologies, Inc. · Oct 1997