Cleared Traditional

ROCHE-TDM ONLEIN(TM) CONTROLS (K946119) - FDA 510(k) Clearance

Class I Toxicology device.

K946119 · Roche Diagnostic Systems, Inc. · Toxicology device
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Feb 1995
Decision
54d
Days
Class 1
Risk

K946119 is an FDA 510(k) clearance for the ROCHE-TDM ONLEIN(TM) CONTROLS. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 54 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 K946119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1994
Decision Date February 07, 1995
Days to Decision 54 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
33d faster than avg
Panel avg: 87d · This submission: 54d
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 82
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K946119.
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · Roche Diagnostic Systems, Inc. · Jan 1994
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · Roche Diagnostic Systems, Inc. · Jan 1992
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · Roche Diagnostic Systems, Inc. · Aug 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107 · 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