Cleared Traditional

K920858 - IL TEST METHADONE

K920858 is the FDA 510(k) clearance for IL TEST METHADONE by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K920858 · Instrumentation Laboratory CO · Toxicology device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
59d
Days
Class 2
Risk

K920858 is an FDA 510(k) clearance for the IL TEST METHADONE. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on April 24, 1992 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K920858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date April 24, 1992
Days to Decision 59 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
28d faster than avg
Panel avg: 87d · This submission: 59d
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 38
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K920858.
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
METHADONE METABOLITE EIA ASSAY
K931780 · Diagnostic Reagents, Inc. · Aug 1993
SYVA EMIT II METHADONE ASSAY
K920751 · Syva Co. · Mar 1992
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
K911954 · Bio-Rad · May 1991
TDX METHADONE ASSAY
K884968 · Abbott Laboratories · Dec 1988