Cleared Traditional

K133156 - ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY (FDA 510(k) Clearance)

Also includes:
ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 45
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K133156.
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
K232587 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Apr 2024
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · Immunostics Inc., · Sep 2023
Access 25(OH) Vitamin D Total
K223503 · Beckman Coulter, Inc. · Jan 2023
Elecsys Vitamin D total III
K210901 · Roche Diagnostics · Sep 2021