Cleared Traditional

DRUGS OF ABUSE CONTROLS (K935285) - FDA 510(k) Clearance

Class I Toxicology device.

K935285 · Medical Diagnostic Technologies, Inc. · Toxicology device
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Mar 1994
Decision
139d
Days
Class 1
Risk

K935285 is an FDA 510(k) clearance for the DRUGS OF ABUSE CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 139 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K935285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1993
Decision Date March 22, 1994
Days to Decision 139 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 87d · This submission: 139d
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 78
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K935285.
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · Roche Diagnostic Systems, Inc. · Jan 1995
ABUSCREEN ONLINE CONTROLS
K945194 · Roche Diagnostic Systems, Inc. · Dec 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114 · Roche Diagnostic Systems, Inc. · Sep 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co. · Jan 1994
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · Roche Diagnostic Systems, Inc. · Aug 1993
ABUSCREEN ONLINE CONTROL
K931125 · Roche Diagnostic Systems, Inc. · Aug 1993