Cleared Traditional

K943999 - ABUSCREEN ONTRAK POSITIVE CONTROL

K943999 is the FDA 510(k) clearance for ABUSCREEN ONTRAK POSITIVE CONTROL by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K943999 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jan 1995
Decision
187d
Days
Class 1
Risk

K943999 is an FDA 510(k) clearance for the ABUSCREEN ONTRAK POSITIVE CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 25, 1995 after a review of 187 days - an extended review 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: 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K943999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date January 25, 1995
Days to Decision 187 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
100d slower than avg
Panel avg: 87d · This submission: 187d
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 131
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K943999.
ABUSCREEN ONLINE DRUG FREE URINE
K953845 · Roche Diagnostic Systems, Inc. · Sep 1995
MULTI-DRUG CONTROL SET
K951135 · Microgenics Corp. · Apr 1995
DRUGS OF ABUSE CONTROLS
K950138 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
ABUSCREEN ONLINE CONTROLS
K945194 · Roche Diagnostic Systems, Inc. · Dec 1994
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257 · Medical Diagnostic Technologies, Inc. · Sep 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114 · Roche Diagnostic Systems, Inc. · Sep 1994