Cleared Traditional

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (K042927) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042927 · Greiner Bio-One Vacuette North America · Chemistry device
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Apr 2005
Decision
175d
Days
Class 2
Risk

K042927 is an FDA 510(k) clearance for the VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES. Classified as Blood/plasma Collection Device For Dna Testing (product code PJE), Class II - Special Controls.

Submitted by Greiner Bio-One Vacuette North America (Baldwin, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 175 days - an extended review cycle.

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.

View all Greiner Bio-One Vacuette North America devices

Submission Details

510(k) Number K042927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2004
Decision Date April 15, 2005
Days to Decision 175 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 88d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.