Cleared Traditional

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL (K063224) - FDA 510(k) Clearance

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

K063224 · Gentris Corporation · Chemistry device
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Dec 2006
Decision
59d
Days
Class 2
Risk

K063224 is an FDA 510(k) clearance for the GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL. Classified as Quality Control Material, Genetics, Dna (product code NZB), Class II - Special Controls.

Submitted by Gentris Corporation (Morrisville, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5910 - the FDA in vitro diagnostics and chemistry 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 Gentris Corporation devices

Submission Details

510(k) Number K063224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2006
Decision Date December 22, 2006
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
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 Chemistry devices follow this clearance model.