Cleared Traditional

K946119 - ROCHE-TDM ONLEIN(TM) CONTROLS

K946119 is the FDA 510(k) clearance for ROCHE-TDM ONLEIN(TM) CONTROLS by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K946119 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 53
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K946119.
MICROGENICS CYCLOSPORINE CONTROL KIT
K032842 · Microgenics Corp. · Oct 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · Microgenics Corp. · Mar 2003
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · Beckman Instruments, Inc. · Apr 1997
MICROGENICS THC CONTROL SETS
K943048 · Microgenics Corp. · Aug 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · Roche Diagnostic Systems, Inc. · Jan 1994
DUPONT ACA URINE METHADONE CONTROL
K934145 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993