Cleared Traditional

K133156 - ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY

Also marketed or referenced as:
ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA

K133156 is an FDA 510(k) clearance for ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY, manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K133156 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
280d
Days
Class 2
Risk

K133156 is an FDA 510(k) clearance for the ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 280 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1825 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K133156

510(k) Number K133156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date July 24, 2014
Days to Decision 280 days
Submission Type Traditional
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
192d slower than avg
Panel avg: 88d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRG Device Classification - Class 2, Special Controls

Product Code MRG System, Test, Vitamin D
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1825
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 - MRG System, Test, Vitamin D

All 43
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K133156.
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LIASON XL1,25 DIHYDROXYVITAMIN D
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DIAZYME 25-OH VITAMIN D ASSAY
K133410 · Diazyme Laboratories · Mar 2014
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc. · Sep 2013
25-OH VITAMIN D ELISA
K123660 · Euroimmun US · Jul 2013