Cleared Traditional

K081378 - DRI METHADONE METABOLITE (100/300) ASSAY

K081378 is the FDA 510(k) clearance for DRI METHADONE METABOLITE (100/300) ASSAY by Thermo Fisher Scientific. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K081378 · Thermo Fisher Scientific · Toxicology device
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Optimized for regulatory review, auditing and printing
Jan 2009
Decision
243d
Days
Class 2
Risk

K081378 is an FDA 510(k) clearance for the DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Fremont Blvd., US). The FDA issued a Cleared decision on January 14, 2009 after a review of 243 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 Thermo Fisher Scientific devices

Submission Details

510(k) Number K081378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2008
Decision Date January 14, 2009
Days to Decision 243 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 87d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K081378.
RANDOX METHADONE ASSAY
K092272 · Randox Laboratories, Ltd. · Nov 2010
RANDOX METABOLITE (EDDP) ASSAY
K092258 · Randox Laboratories, Ltd. · Nov 2010
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · Biosite Incorporated · Apr 2010
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · Biosite Incorporated · Jun 2006
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K051058 · Lin-Zhi International, Inc. · Mar 2006