Cleared Traditional

K903824 - DRUG OF ABUSE ANALYSIS SYSTEM FREE RADI...

K903824 is the FDA 510(k) clearance for DRUG OF ABUSE ANALYSIS SYSTEM FREE RADI... by Technicon Instruments Corp.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K903824 · Technicon Instruments Corp. · Toxicology device
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Sep 1990
Decision
38d
Days
Class 2
Risk

K903824 is an FDA 510(k) clearance for the DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 27, 1990 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K903824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date September 27, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 87d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K903824.
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993 · Immunotech Corp. · Dec 1990
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115 · Hycor Biomedical, Inc. · Nov 1990
MILENIA (TM) METHAMPHETAMINE
K904451 · Diagnostic Products Corp. · Nov 1990
MILENIA (TM) AMPHETAMINE
K902979 · Diagnostic Products Corp. · Sep 1990
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
K900995 · Syva Co. · Apr 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · Roche Diagnostic Systems, Inc. · Mar 1990