Cleared Traditional

K903825 - DRUG OF ABUSE ANALYSIS SYSTEM (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 99
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K903825.
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