Cleared Special

K060417 - MODIFICATION TO QUANTIMETRIX URINE DRUG...

K060417 is the FDA 510(k) clearance for MODIFICATION TO QUANTIMETRIX URINE DRUG... by Quantimetrix Corp.. It is a Class 1 Toxicology device (product code DIF) cleared through the Special 510(k) pathway after a 32-day FDA review.

K060417 · Quantimetrix Corp. · Toxicology device
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Mar 2006
Decision
32d
Days
Class 1
Risk

K060417 is an FDA 510(k) clearance for the MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Quantimetrix Corp. (Redondo Beach, US). The FDA issued a Cleared decision on March 21, 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K060417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2006
Decision Date March 21, 2006
Days to Decision 32 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
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
Modification to existing cleared device.

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 110
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K060417.
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
K120504 · Bio-Rad Laboratories, Inc. · Mar 2012
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
K080183 · Roche Diagnostics Corp. · Mar 2008
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
K062191 · Dade Behring, Inc. · Aug 2006
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053 · Bio-Rad · Aug 2005
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682 · Bio-Rad Laboratories, Inc. · Apr 2005
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · Bio-Rad · Nov 2004