Cleared Traditional

K063357 - MINICOLLECT CAPILLARY BLOOD COLLECTION ...

K063357 is an FDA 510(k) clearance for MINICOLLECT CAPILLARY BLOOD COLLECTION ..., manufactured by Greiner Bio-One North America, Inc.. The device is a Class 2 Hematology device with product code JKA cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K063357 · Greiner Bio-One North America, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K063357

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.

JKA Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K063357.
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
K090737 · Bio-Rad Laboratories, Inc. · Jun 2009
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING
K081229 · Smiths Medical Asd, Inc. · Jul 2008
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
K072783 · Smiths Medical Asd, Inc. · Nov 2007
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
K060364 · Teco Diagnostics · Jun 2006
SAFEPICO
K043143 · Radiometer Medical Aps · Apr 2005
CYTO-CHEX BCT
K040107 · Streck Laboratories, Inc. · Jul 2004