Cleared Traditional

K083171 - INTROL CF PANEL I CONTROL, MODEL: G106 (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083171 · Maine Molecular Quality Controls, Inc. · Pathology device
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
50d
Days
Class 2
Risk

K083171 is an FDA 510(k) clearance for the INTROL CF PANEL I CONTROL, MODEL: G106. 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 Cleared decision on December 16, 2008 after a review of 50 days - a notably fast clearance cycle.

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 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 Maine Molecular Quality Controls, Inc. devices

Submission Details

510(k) Number K083171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2008
Decision Date December 16, 2008
Days to Decision 50 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 77d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.