Cleared Traditional

K023626 - AML HAIRCHECK-DT (COCAINE)

K023626 is an FDA 510(k) clearance for AML HAIRCHECK-DT (COCAINE), manufactured by Quest Diagnostics, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K023626

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.

DIO Device Classification - Class 2, Special Controls

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 117
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