Cleared Traditional

K903909 - BLIND CONTROLS FOR DRUGS OF ABUSE TESTING

K903909 is the FDA 510(k) clearance for BLIND CONTROLS FOR DRUGS OF ABUSE TESTING by Rapid Diagnostic Laboratories, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K903909 · Rapid Diagnostic Laboratories, Inc. · Toxicology device
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Oct 1990
Decision
65d
Days
Class 1
Risk

K903909 is an FDA 510(k) clearance for the BLIND CONTROLS FOR DRUGS OF ABUSE TESTING. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Rapid Diagnostic Laboratories, Inc. (Port Washington, US). The FDA issued a Cleared decision on October 26, 1990 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Rapid Diagnostic Laboratories, Inc. devices

Submission Details

510(k) Number K903909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1990
Decision Date October 26, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K903909.
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
K911168 · Analytical Control Systems, Inc. · May 1991
CHALLENGE (TM) LIQ THERA DRUG CONTROLS
K910333 · Medical Analysis Systems, Inc. · Apr 1991
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
K904905 · Medical Analysis Systems, Inc. · Dec 1990
KODATROL LIQUID CONTROL LEVELS I & II
K903189 · Eastman Kodak Company · Aug 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN
K901270 · Bio-Rad · May 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271 · Bio-Rad · Apr 1990