Cleared Special

K082150 - MODIFICATION TO PAXGENE BLOOD RNA SYSTEM (FDA 510(k) Clearance)

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

K082150 · Preanalytix GmbH · Pathology device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
189d
Days
Class 2
Risk

K082150 is an FDA 510(k) clearance for the MODIFICATION TO 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 Cleared decision on February 4, 2009 after a review of 189 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.4070 - the FDA pathology 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K082150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2008
Decision Date February 04, 2009
Days to Decision 189 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 77d · This submission: 189d
Pathway characteristics
Modification to existing cleared device.

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.