Cleared Traditional

K080381 - QUEST DIAGNOSTICS METHAMPHETAMINE MICRO...

K080381 is the FDA 510(k) clearance for QUEST DIAGNOSTICS METHAMPHETAMINE MICRO... by Quest Diagnostics, Inc.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K080381 · Quest Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
133d
Days
Class 2
Risk

K080381 is an FDA 510(k) clearance for the QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Quest Diagnostics, Inc. (Lenexa, US). The FDA issued a Cleared decision on June 25, 2008 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 K080381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date June 25, 2008
Days to Decision 133 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 87d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 32
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K080381.
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
K112236 · Guangzhou Wondfo Biotech Co., Ltd. · Sep 2011
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K101753 · Microgenics Corp. · Apr 2011
ROCHE FLUDI METHAMPHETAMINE
K093884 · Roche Diagnostics · Feb 2011
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242 · Lin-Zhi International, Inc. · Sep 2006
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577 · Immunalysis Corporation · Oct 2005
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299 · ACON Laboratories, Inc. · Dec 2003