Cleared Traditional

K023626 - AML HAIRCHECK-DT (COCAINE)

K023626 is the FDA 510(k) clearance for AML HAIRCHECK-DT (COCAINE) by Quest Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K023626 · Quest Diagnostics, Inc. · Toxicology device
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Sep 2003
Decision
335d
Days
Class 2
Risk

K023626 is an FDA 510(k) clearance for the AML HAIRCHECK-DT (COCAINE). Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Quest Diagnostics, Inc. (Las Vegas, US). The FDA issued a Cleared decision on September 29, 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 862.3250 - 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 Quest Diagnostics, Inc. devices

Submission Details

510(k) Number K023626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date September 29, 2003
Days to Decision 335 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
248d slower than avg
Panel avg: 87d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K023626.
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
K032903 · ACON Laboratories, Inc. · Feb 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · Dade Behring, Inc. · Feb 2004
RANDOX EVIDENCE
K030360 · Randox Laboratories, Ltd. · Dec 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · Dade Behring, Inc. · Jul 2003
ONLINE DAT II COCAINE II
K023281 · Roche Diagnostics Corp. · Dec 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296 · Roche Diagnostics Corp. · Nov 2002