Cleared Traditional

K920418 - IL TEST CANNABINOID

K920418 is the FDA 510(k) clearance for IL TEST CANNABINOID by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K920418 · Instrumentation Laboratory CO · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 1992
Decision
27d
Days
Class 2
Risk

K920418 is an FDA 510(k) clearance for the IL TEST CANNABINOID, 35282. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 K920418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date February 27, 1992
Days to Decision 27 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
60d faster than avg
Panel avg: 87d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 72
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K920418.
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · Microgenics Corp. · Jan 1994
EMIT(R) THC 50/100 NG ASSAY
K932716 · Syva Co. · Oct 1993
CANNABINOID EIA TEST
K920311 · Diagnostic Reagents, Inc. · Feb 1992
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
K912757 · Roche Diagnostic Systems, Inc. · Jul 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · Roche Diagnostic Systems, Inc. · Jun 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589 · Roche Diagnostic Systems, Inc. · Apr 1991