Cleared Traditional

K913742 - IL TEST(TM) OPIATE

K913742 is the FDA 510(k) clearance for IL TEST(TM) OPIATE by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K913742 · Instrumentation Laboratory CO · Toxicology device
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Nov 1991
Decision
79d
Days
Class 2
Risk

K913742 is an FDA 510(k) clearance for the IL TEST(TM) OPIATE. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 7, 1991 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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.

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Submission Details

510(k) Number K913742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date November 07, 1991
Days to Decision 79 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
8d faster than avg
Panel avg: 87d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 107
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K913742.
CEDIA(R) DAU OPIATE ASSAY
K935346 · Microgenics Corp. · Jan 1994
EMIT(R) IIC OPIATE ASSAY
K935117 · Syva Co. · Jan 1994
OPIATE EIA ASSAY
K915180 · Diagnostic Reagents, Inc. · Jan 1992
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · Roche Diagnostic Systems, Inc. · Dec 1990
EMIT(R) II OPIATE ASSAY
K902577 · Syva Co. · Jul 1990
MILENIA(TM) OPIATES
K901577 · Diagnostic Products Corp. · May 1990