Not Cleared Post-NSE

DEN060007 - INTROL CF PANEL I CONTROL (FDA 510(k) Clearance)

Class II Pathology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN060007 · Maine Molecular Quality Controls, Inc. · Pathology device
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Oct 2006
Decision
59d
Days
Class 2
Risk

DEN060007 is an FDA 510(k) submission (not cleared) for the INTROL CF PANEL I CONTROL. Classified as Quality Control Material, Genetics, Dna (product code NZB), Class II - Special Controls.

Submitted by Maine Molecular Quality Controls, Inc. (Scarborough, US). The FDA issued a Not Cleared (DENG) decision on October 12, 2006 after a review of 59 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5910 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

View all Maine Molecular Quality Controls, Inc. devices

Submission Details

510(k) Number DEN060007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 14, 2006
Decision Date October 12, 2006
Days to Decision 59 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 77d · This submission: 59d
Pathway characteristics

Device Classification

Product Code NZB Quality Control Material, Genetics, Dna
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5910
Definition Dna Quality Control Material For Genetic Testing Is A Device Intended For Medical Purposes For Use In A Test System To Estimate Test Precision And To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation. This Type Of Device Includes Synthetic Dna Controls And Cell-line Based Controls.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.