# K110586: Advia Centaur Vitamin D Total Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 14, 2011 after 227 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950469 (1995). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021163: Octeia 25-Hydroxy Vitamin D, Immunodiagnostic Systems, Ltd. (2002) Summary page 2.
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901, Maine Standards Co. (2006) Summary page 2.

## Most influential descendants
- K133156: Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total Calibrators,Quality Control & Master Control Materia (2014), 1 descendant of its own
- K200509: ADVIA Centaur Vitamin D Total (VitD) (2020), 0 descendants of its own
- K162298: LOCI Total Vitamin D Total Assay, LOCI VITD CAL (2017), 0 descendants of its own

## Recalls of this device
- Oct 5, 2016 · Class II · Z-0398-2017: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
- Oct 5, 2016 · Class II · Z-0397-2017: Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples
- Apr 10, 2014 · Class II · Z-1656-2014: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
- Apr 10, 2014 · Class II · Z-1655-2014: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
- Apr 10, 2014 · Class II · Z-1658-2014: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
- Apr 10, 2014 · Class II · Z-1657-2014: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
- Feb 16, 2012 · Not classified · Z-1268-2012: Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.

## Indications for use
The ADVIA Centaur Vitamin D Total (VitD) assay is for the 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 is 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/K110586
Methodology: https://510kreport.com/methodology