Cleared Special

K231469 - PAXgene® Blood DNA Tube (FDA 510(k) Clearance)

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

K231469 · Preanalytix GmbH · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 2023
Decision
30d
Days
Class 2
Risk

K231469 is an FDA 510(k) clearance for the PAXgene® Blood DNA Tube. Classified as Blood/plasma Collection Device For Dna Testing (product code PJE), Class II - Special Controls.

Submitted by Preanalytix GmbH (Hombrechtikon, CH). The FDA issued a Cleared decision on June 21, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Preanalytix GmbH devices

Submission Details

510(k) Number K231469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2023
Decision Date June 21, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PJE Blood/plasma Collection Device For Dna Testing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition A Blood Collection Device For Dna Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical Dna 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 Chemistry devices follow this clearance model.