Cleared Special

K140496 - Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents

K140496 is an FDA 510(k) clearance for Access Vitamin B12 Assay, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code CDD cleared through the Special 510(k) pathway after a 201-day FDA review.

K140496 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
201d
Days
Class 2
Risk

K140496 is an FDA 510(k) clearance for the Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access .... 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 September 16, 2014 after a review of 201 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140496

510(k) Number K140496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2014
Decision Date September 16, 2014
Days to Decision 201 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
113d slower than avg
Panel avg: 88d · This submission: 201d
Pathway characteristics
Modification to existing cleared device.

CDD Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K140496.
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
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K160757 · Axis-Shield Diagnostics Limited · Jul 2016
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
K151786 · Roche Diagnostics · Sep 2015
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
K133512 · Siemens Healthcare Diagnostics · Jan 2014
AXIS-SHIELD ACVTIVE-B12
K121946 · Axis-Shield Diagnostics, Ltd. · Mar 2013
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
K121994 · Siemens Healthcare Diagnostics, Inc. · Nov 2012
K140496 · Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
Download PDF FDA Summary Beckman Coulter, Inc.