Cleared Traditional

K101973 - OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

K101973 is an FDA 510(k) clearance for OMEGA LABORATORIES HAIR DRUG SCREENING ..., manufactured by Omega Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LAF cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K101973 · Omega Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
399d
Days
Class 2
Risk

K101973 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYL.... Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Omega Laboratories, Inc. (South Lyon, US). The FDA issued a Cleared decision on August 16, 2011 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3610 - 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. Elevated predicate reliance profile. 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 Omega Laboratories, Inc. devices

FDA 510(k) Submission Details - K101973

510(k) Number K101973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2010
Decision Date August 16, 2011
Days to Decision 399 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 88d · This submission: 399d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAF Device Classification - Class 2, Special Controls

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 Chemistry devices follow this clearance model.

Regulatory Peers - LAF Gas Chromatography, Methamphetamine

All 40
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K101973.
PSYCHEMEDICS METHAMPHETAMINE EIA
K111927 · Psychemedics Corp. · May 2012
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
K113661 · Lin-Zhi International, Inc. · Jan 2012
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