Cleared Traditional

K031359 - S-MONOVETTE EDTA K2-GEL

K031359 is an FDA 510(k) clearance for S-MONOVETTE EDTA K2-GEL, manufactured by Sarstedt, Inc.. The device is a Class 2 Chemistry device with product code PJE cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K031359 · Sarstedt, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
135d
Days
Class 2
Risk

K031359 is an FDA 510(k) clearance for the S-MONOVETTE EDTA K2-GEL. Classified as Blood/plasma Collection Device For Dna Testing (product code PJE), Class II - Special Controls.

Submitted by Sarstedt, Inc. (Newton, US). The FDA issued a Cleared decision on September 12, 2003 after a review of 135 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K031359

510(k) Number K031359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date September 12, 2003
Days to Decision 135 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 88d · This submission: 135d
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 Chemistry 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 K031359.
PAXgene® Blood DNA Tube
K231469 · Preanalytix GmbH · Jun 2023
PAXgene Blood DNA Tube
K142821 · Preanalytix GmbH · Sep 2015
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
K042927 · Greiner Bio-One Vacuette North America · Apr 2005
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
K031359 · S-MONOVETTE EDTA K2-GEL
Download PDF Sarstedt, Inc.