Cleared Traditional

K142821 - PAXgene Blood DNA Tube

K142821 is an FDA 510(k) clearance for PAXgene Blood DNA Tube, manufactured by Preanalytix GmbH. The device is a Class 2 Toxicology device with product code PJE cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K142821 · Preanalytix GmbH · Toxicology device
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Sep 2015
Decision
344d
Days
Class 2
Risk

K142821 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 September 9, 2015 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - the FDA toxicology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Preanalytix GmbH devices

FDA 510(k) Submission Details - K142821

510(k) Number K142821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date September 09, 2015
Days to Decision 344 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 87d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PJE Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - PJE Blood/plasma Collection Device For Dna Testing

All 7
Devices cleared under the same product code (PJE) and FDA review panel - the closest regulatory comparables to K142821.
PAXgene® Blood DNA Tube
K231469 · Preanalytix GmbH · Jun 2023
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
K042927 · Greiner Bio-One Vacuette North America · Apr 2005
S-MONOVETTE EDTA K2-GEL
K031359 · Sarstedt, Inc. · Sep 2003
VACUETTE EDTA K2 TUBES
K014104 · Greiner Vacuette North America, Inc. · Feb 2002
VACUETTE EDTA K2 GEL TUBES
K012043 · Greiner Vacuette North America, Inc. · Sep 2001
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
K010328 · Izon Business Products, Inc. · Apr 2001