Cleared Special

K060417 - MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

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

K060417 · Quantimetrix Corp. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K060417

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

DIF Device Classification - Class 1, General Controls

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 184
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K060417.
ESA LEADCARE II LEAD CONTROL
K063398 · Bionostics, Inc. · Dec 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
K062191 · Dade Behring, Inc. · Aug 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · Biosite Incorporated · Jul 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
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · Biosite Incorporated · Mar 2005
K060417 · MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
Download PDF FDA Summary Quantimetrix Corp.