Cleared Traditional

K152232 - Quest Diagnostics HairCheck-DT (Cocaine)

K152232 is an FDA 510(k) clearance for Quest Diagnostics HairCheck-DT (Cocaine), manufactured by Quest Diagnostics Incorporated. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K152232 · Quest Diagnostics Incorporated · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
469d
Days
Class 2
Risk

K152232 is an FDA 510(k) clearance for the Quest Diagnostics HairCheck-DT (Cocaine). Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Quest Diagnostics Incorporated (Lenexa, US). The FDA issued a Cleared decision on November 18, 2016 after a review of 469 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Quest Diagnostics Incorporated devices

FDA 510(k) Submission Details - K152232

510(k) Number K152232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date November 18, 2016
Days to Decision 469 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
382d slower than avg
Panel avg: 87d · This submission: 469d
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 116
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K152232.
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RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
K142129 · Biophor Diagnostics, Inc. · Jul 2015