# K133156: Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total Calibrators,Quality Control & Master Control Materia

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 24, 2014 after 280 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950469 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110586: Advia Centaur Vitamin D Total Assay, Siemens Healthcare Diagnostics, Inc. (2011) Summary page 4.

## Most influential descendants
- K200509: ADVIA Centaur Vitamin D Total (VitD) (2020), 0 descendants of its own

## Indications for use
The ADVIA Centaur Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency. The ADVIA Centaur Vitamin D Total (VitD) Calibrators are for in vitro diagnostic use in calibrating ADVIA Centaur systems Vitamin D Total (VitD) assay. The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur VitD assay on the ADVIA Centaur systems. The ADVIA Centaur Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.

Source page: https://510kreport.com/device/K133156
Methodology: https://510kreport.com/methodology