Cleared Special

K103041 - VACUETTE BLOOD COLLECTION TUBE WITH LIT...

K103041 is an FDA 510(k) clearance for VACUETTE BLOOD COLLECTION TUBE WITH LIT..., manufactured by Greiner Bio-One North America, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Special 510(k) pathway after a 26-day FDA review.

K103041 · Greiner Bio-One North America, Inc. · Chemistry device
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Nov 2010
Decision
26d
Days
Class 2
Risk

K103041 is an FDA 510(k) clearance for the VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR. 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 November 9, 2010 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

FDA 510(k) Submission Details - K103041

510(k) Number K103041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2010
Decision Date November 09, 2010
Days to Decision 26 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 Chemistry 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 K103041.
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