Cleared Traditional

K040257 - QUEST DIAGNOSTICS HAIRCHECK-DT (THC)

K040257 is the FDA 510(k) clearance for QUEST DIAGNOSTICS HAIRCHECK-DT (THC) by Quest Diagnostics, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K040257 · Quest Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
131d
Days
Class 2
Risk

K040257 is an FDA 510(k) clearance for the QUEST DIAGNOSTICS HAIRCHECK-DT (THC). Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Quest Diagnostics, Inc. (Las Vegas, US). The FDA issued a Cleared decision on June 14, 2004 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 Quest Diagnostics, Inc. devices

Submission Details

510(k) Number K040257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2004
Decision Date June 14, 2004
Days to Decision 131 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
44d slower than avg
Panel avg: 87d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K040257.
ON CALL MULTI-DRUG HOME TEST CUP
K050878 · ACON Laboratories, Inc. · Jun 2005
ON CALL MULTI-DRUG HOME TEST
K050050 · ACON Laboratories, Inc. · Mar 2005
RANDOX CANNABINOIDS ASSSAY
K041142 · Randox Laboratories, Ltd. · Nov 2004
ONLINE DAT II CANNABINOIDS II
K030213 · Roche Diagnostics Corp. · Apr 2003
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · Lin-Zhi International, Inc. · Aug 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
K014066 · Princeton BioMeditech Corp. · Jun 2002