Cleared Traditional

K943999 - ABUSCREEN ONTRAK POSITIVE CONTROL

K943999 is an FDA 510(k) clearance for ABUSCREEN ONTRAK POSITIVE CONTROL, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Toxicology device with 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

FDA 510(k) Submission Details - K943999

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.

DIF Device Classification - Class 1, General Controls

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 174
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K943999.
IMMUNOASSAY DRUGS OF ABUSE CONTROLS
K952056 · Medi-Tech, Inc. · Jun 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
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551 · Medi-Tech, Inc. · Oct 1994
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257 · Medical Diagnostic Technologies, Inc. · Sep 1994