Cleared Traditional

K914806 - ABUSCREEN ONTRAK POSITIVE REFERENCE CON...

K914806 is the FDA 510(k) clearance for ABUSCREEN ONTRAK POSITIVE REFERENCE CON... by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K914806 · Roche Diagnostic Systems, Inc. · Toxicology device
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Nov 1991
Decision
26d
Days
Class 1
Risk

K914806 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 26 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K914806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1991
Decision Date November 19, 1991
Days to Decision 26 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
61d faster than avg
Panel avg: 87d · This submission: 26d
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 K914806.
COBAS-FP TDM CONTROLS
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K914170 · Bio-Rad · Nov 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724 · E.I. Dupont DE Nemours & Co., Inc. · May 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
K910930 · Analytical Control Systems, Inc. · May 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
K911167 · Analytical Control Systems, Inc. · May 1991