Cleared Traditional

K903825 - DRUG OF ABUSE ANALYSIS SYSTEM

K903825 is the FDA 510(k) clearance for DRUG OF ABUSE ANALYSIS SYSTEM by Technicon Instruments Corp.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K903825 · Technicon Instruments Corp. · Toxicology device
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Sep 1990
Decision
38d
Days
Class 2
Risk

K903825 is an FDA 510(k) clearance for the DRUG OF ABUSE ANALYSIS SYSTEM. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), 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 862.3150 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K903825 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 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 67
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K903825.
EMIT(R) II BARBITURATE ASSAY
K926068 · Syva Co. · Jan 1993
BARBITURATE EIA TEST
K925491 · Diagnostic Reagents, Inc. · Dec 1992
IL TEST BARBITURATE, 35289
K920417 · Instrumentation Laboratory CO · Apr 1992
EMIT(R) II BARBITURATE ASSAY
K902580 · Syva Co. · Jul 1990
TDX(R) BARBITURATES II ASSAY
K896550 · Abbott Laboratories · Dec 1989
ADX TM BARBITURATES
K890690 · Abbott Laboratories · Aug 1989