Cleared Traditional

MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES (K063357) - FDA 510(k) Clearance

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

K063357 · Greiner Bio-One North America, Inc. · Hematology device
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Jul 2007
Decision
245d
Days
Class 2
Risk

K063357 is an FDA 510(k) clearance for the MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Bio-One North America, Inc. (Baldwin, US). The FDA issued a Cleared decision on July 10, 2007 after a review of 245 days - an extended review cycle.

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

View all Greiner Bio-One North America, Inc. devices

Submission Details

510(k) Number K063357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2006
Decision Date July 10, 2007
Days to Decision 245 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 113d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Hematology devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 101
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K063357.
BD Vacutainer UltraTouch Push Button Blood Collection Set
K153309 · Becton, Dickinson and Company · Feb 2016
BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
K101502 · Becton, Dickinson & CO · Jun 2010
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
K093972 · Becton, Dickinson & CO · Jan 2010
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
K041071 · Becton, Dickinson & CO · May 2004
BD VACUTAINER SST II PLUS TUBES
K023331 · Becton, Dickinson & CO · Nov 2002
MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
K022875 · Becton, Dickinson & CO · Sep 2002