Cleared Traditional

K112808 - OMEGA LABORATORIES HAIR DRUG SCREENING ...

K112808 is the FDA 510(k) clearance for OMEGA LABORATORIES HAIR DRUG SCREENING ... by Omega Laboratories, Inc.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K112808 · Omega Laboratories, Inc. · Toxicology device
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Jan 2012
Decision
118d
Days
Class 2
Risk

K112808 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Omega Laboratories, Inc. (Mogadore, US). The FDA issued a Cleared decision on January 23, 2012 after a review of 118 days - within the typical 510(k) review window.

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: 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 Omega Laboratories, Inc. devices

Submission Details

510(k) Number K112808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date January 23, 2012
Days to Decision 118 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
31d slower than avg
Panel avg: 87d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K112808.
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
K131754 · Guangzhou Wondfo Biotech Co., Ltd. · Jul 2013
RANDOX COCAINE METABOLITE
K113751 · Randox Laboratories, Ltd. · May 2012
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
K121166 · Guangzhou Wondfo Biotech Co., Ltd. · May 2012
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
K113139 · Lin-Zhi International, Inc. · Nov 2011
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
K112071 · Guangzhou Wondfo Biotech Co., Ltd. · Sep 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742 · Microgenics Corp. · Apr 2011