Cleared Traditional

K931780 - METHADONE METABOLITE EIA ASSAY

K931780 is the FDA 510(k) clearance for METHADONE METABOLITE EIA ASSAY by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K931780 · Diagnostic Reagents, Inc. · Toxicology device
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Aug 1993
Decision
136d
Days
Class 2
Risk

K931780 is an FDA 510(k) clearance for the METHADONE METABOLITE EIA ASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 136 days - within the typical 510(k) review window.

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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K931780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1993
Decision Date August 23, 1993
Days to Decision 136 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 87d · This submission: 136d
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 K931780.
METHADONE ENZYME IMMUNOASSAY
K934667 · Diagnostic Reagents, Inc. · Jan 1994
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
K930928 · Roche Diagnostic Systems, Inc. · Sep 1993
IL TEST METHADONE
K920858 · Instrumentation Laboratory CO · Apr 1992
SYVA EMIT II METHADONE ASSAY
K920751 · Syva Co. · Mar 1992
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
K911954 · Bio-Rad · May 1991