Not Cleared Post-NSE

DEN050003 - PAXGENE BLOOD RNA SYSTEM (FDA 510(k) Clearance)

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

DEN050003 · Preanalytix GmbH · Pathology device
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Apr 2005
Decision
49d
Days
Class 2
Risk

DEN050003 is an FDA 510(k) submission (not cleared) for the PAXGENE BLOOD RNA SYSTEM. Classified as System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test (product code NTW), Class II - Special Controls.

Submitted by Preanalytix GmbH (Franklin Lakes, US). The FDA issued a Not Cleared (DENG) decision on April 18, 2005 after a review of 49 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.4070 - 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.

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Submission Details

510(k) Number DEN050003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 28, 2005
Decision Date April 18, 2005
Days to Decision 49 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
28d faster than avg
Panel avg: 77d · This submission: 49d
Pathway characteristics

Device Classification

Product Code NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4070
Definition System For Collection, Storage, And Transport Of Whole Blood And Stabilization Of Intracellular Rna With Subsequent Isolation And Purification Of Host Rna For Rt-pcr Used In Molecular Diagnostic Testing
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.