Cleared Traditional

K042725 - QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)

K042725 is the FDA 510(k) clearance for QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) by Quest Diagnostics, Inc.. It is a Class 2 Chemistry device (product code DJG) cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K042725 · Quest Diagnostics, Inc. · Chemistry device
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Jul 2005
Decision
278d
Days
Class 2
Risk

K042725 is an FDA 510(k) clearance for the QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES). Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Quest Diagnostics, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 6, 2005 after a review of 278 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Quest Diagnostics, Inc. devices

Submission Details

510(k) Number K042725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date July 06, 2005
Days to Decision 278 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 88d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 137
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K042725.
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST
K060527 · Alfa Scientific Designs, Inc. · Jul 2006
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
K060466 · ACON Laboratories, Inc. · Apr 2006
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · Immunalysis Corporation · Oct 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
K050733 · Lin-Zhi International, Inc. · Jun 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · ACON Laboratories, Inc. · Feb 2005
RANDOX OPIATES ASSAY
K041144 · Randox Laboratories, Ltd. · Nov 2004