Cleared Special

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041133 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
63d
Days
Class 2
Risk

K041133 is an FDA 510(k) clearance for the MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 63 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 Bayer Healthcare, LLC devices

Submission Details

510(k) Number K041133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date July 02, 2004
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 45
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K041133.
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224 · Dade Behring, Inc. · Nov 2007
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755 · Roche Diagnostics Corp. · Apr 2006
ABBOTT AXSYM B12
K051327 · Abbott Laboratories · Aug 2005
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · Bayer Corp. · Dec 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
K984321 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
ELECSYS VITAMIN B12 ASSAY
K973702 · Boehringer Mannheim Corp. · Nov 1997