Cleared Traditional

K913107 - ABUSCREEN ONTRAK POSITIVE REF CONT BENZ...

K913107 is the FDA 510(k) clearance for ABUSCREEN ONTRAK POSITIVE REF CONT BENZ... by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K913107 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1991
Decision
31d
Days
Class 1
Risk

K913107 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 31 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 K913107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1991
Decision Date August 12, 1991
Days to Decision 31 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
56d faster than avg
Panel avg: 87d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific 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 - LAS Drug Specific Control Materials

All 53
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K913107.
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · Roche Diagnostic Systems, Inc. · Jan 1992
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
K913677 · Analytical Control Systems, Inc. · Sep 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · Roche Diagnostic Systems, Inc. · Aug 1991
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
K910829 · Bio-Rad · Apr 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689 · Roche Diagnostic Systems, Inc. · Mar 1991
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464 · Roche Diagnostic Systems, Inc. · Aug 1989