Cleared Traditional

COZART EIA OPIATES ORAL FLUID KIT (K024339) - FDA 510(k) Clearance

Class I Toxicology device.

K024339 · Cozart Bioscience , Ltd. · Toxicology device
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Apr 2003
Decision
101d
Days
Class 1
Risk

K024339 is an FDA 510(k) clearance for the COZART EIA OPIATES ORAL FLUID KIT. Classified as Cholinesterase Test Paper (product code DIG), Class I - General Controls.

Submitted by Cozart Bioscience , Ltd. (Oxfordshire Ox14 4ru, GB). The FDA issued a Cleared decision on April 7, 2003 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3240 - 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 K024339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2002
Decision Date April 07, 2003
Days to Decision 101 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 87d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIG Cholinesterase Test Paper
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
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.