Cleared Traditional

K920417 - IL TEST BARBITURATE

K920417 is the FDA 510(k) clearance for IL TEST BARBITURATE by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K920417 · Instrumentation Laboratory CO · Toxicology device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
84d
Days
Class 2
Risk

K920417 is an FDA 510(k) clearance for the IL TEST BARBITURATE, 35289. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), 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 84 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 K920417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date April 24, 1992
Days to Decision 84 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
3d faster than avg
Panel avg: 87d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 57
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K920417.
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · Syva Co. · Jun 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · Syva Co. · Jan 1993
BARBITURATE EIA TEST
K925491 · Diagnostic Reagents, Inc. · Dec 1992
DRUG OF ABUSE ANALYSIS SYSTEM
K903825 · Technicon Instruments Corp. · Sep 1990
EMIT(R) II BARBITURATE ASSAY
K902580 · Syva Co. · Jul 1990
TDX(R) BARBITURATES II ASSAY
K896550 · Abbott Laboratories · Dec 1989