Cleared Traditional

K920477 - DRUG OF ABUSE URINE CONTROL

K920477 is the FDA 510(k) clearance for DRUG OF ABUSE URINE CONTROL by Diagnostic Reagents, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K920477 · Diagnostic Reagents, Inc. · Toxicology device
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Mar 1992
Decision
50d
Days
Class 1
Risk

K920477 is an FDA 510(k) clearance for the DRUG OF ABUSE URINE CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 50 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K920477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1992
Decision Date March 18, 1992
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K920477.
ABUSCREEN ONLINE CONTROL
K931125 · Roche Diagnostic Systems, Inc. · Aug 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · Bio-Rad · Jul 1993
COBAS-FP TDM CONTROLS
K930269 · Roche Diagnostic Systems, Inc. · Feb 1993
LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM)
K914170 · Bio-Rad · Nov 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · Roche Diagnostic Systems, Inc. · Nov 1991
TDM I LINEARITY TEST SET
K913309 · Casco Standards · Sep 1991