Cleared Traditional

K081378 - DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081378 · Thermo Fisher Scientific · Toxicology device
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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.

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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
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 62
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K081378.
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K192433 · Lin-Zhi International, Inc. · Oct 2019
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416 · Lin-Zhi International, Inc. · Jun 2017
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395 · Immunalysis Corporation · Jul 2015