Cleared Traditional

K062942 - QUANTIMETRIX NICOSURE COTININE URINE CO...

K062942 is the FDA 510(k) clearance for QUANTIMETRIX NICOSURE COTININE URINE CO... by Quantimetrix Corp.. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K062942 · Quantimetrix Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
32d
Days
Class 1
Risk

K062942 is an FDA 510(k) clearance for the QUANTIMETRIX NICOSURE COTININE URINE CONTROL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Quantimetrix Corp. (Redondo Beach, US). The FDA issued a Cleared decision on October 30, 2006 after a review of 32 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 Quantimetrix Corp. devices

Submission Details

510(k) Number K062942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date October 30, 2006
Days to Decision 32 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
55d faster than avg
Panel avg: 87d · This submission: 32d
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 52
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K062942.
MAS IMMUNOSUPPRESSANT CONTROLS
K051074 · Microgenics Corp. · Jun 2005
DRI OXYCODONE ASSAY
K040411 · Microgenics Corp. · May 2004
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
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119 · Roche Diagnostic Systems, Inc. · Feb 1995