Cleared Special

K110413 - POWER PROCESSOR SAMPLE PROCESSING SYSTE...

K110413 is the FDA 510(k) clearance for POWER PROCESSOR SAMPLE PROCESSING SYSTE... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code CDD) cleared through the Special 510(k) pathway after a 86-day FDA review.

K110413 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
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May 2011
Decision
86d
Days
Class 2
Risk

K110413 is an FDA 510(k) clearance for the POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 11, 2011 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K110413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date May 11, 2011
Days to Decision 86 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 - CDD Radioassay, Vitamin B12

All 49
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K110413.
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
K121994 · Siemens Healthcare Diagnostics, Inc. · Nov 2012
ARCHITECT B12
K121314 · Abbott Laboratories · May 2012
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · Abbott Laboratories · Oct 2011
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · Siemens Healthcare Diagnostics · Feb 2010
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
K090588 · Beckman Coulter, Inc. · May 2009
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224 · Dade Behring, Inc. · Nov 2007