510(k) · Cleared
Recalled · Class II · 2016Advia Centaur Vitamin D Total Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · MRG System, Test, Vitamin D
Cleared on Oct 14, 2011 as substantially equivalent to K021163 (Immunodiagnostic Systems, Ltd., 2002) and 1 other predicate after a 227-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 14, 2011
- Review
- 227 days
- Class
- Class II
- Product code
- MRG
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950469 (1995). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
- 2 generations backK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
- 1 generation backK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
- This deviceK110586 Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK133156 Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK200509 ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK162298 LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics · 2017
Most influential descendants
Showing 3 of 3 · See all- K133156Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total Calibrators,Quality…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly1descendant
- K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc. · 2020 · 2 generations on0descendants
- K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950469 | Document Serum Multianalyte Calibration Verification Test Set | Casco Standards | 1995 | — |
| −2 | K992034 | Document Thyroid Cal*Ver | Casco-Nerl Diagnostics Corporation (Maine) | 1999 | — |
| −1 | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 | Maine Standards Co. | 2006 | — |
| 0 (this device) | K110586 | Advia Centaur Vitamin D Total Assay | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
| +1 | K133156 | Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | 2020 | — |
| +1 | K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRG device
- #1 K221817 ALFIS Vitamin D, ALFIS-3 Analyzerscore 8.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021163 | Octeia 25-Hydroxy Vitamin DSummary page 2…Device Device Name IDS 25-Hydroxy Vitamin D EIA Common name Vitamin 0 Test System 510(k) Number K021163 Manufacturer Immunodiagnostic Systems Ltd (IDS Ltd) Master Curve Material Predicate Device… | 2002 |
| * | K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Summary page 2…Set Common name single (specified) Analyte Controls (Assayed and Unassayed) 510(k) Number K062501 Manufacturer Maine Standards Company Device Description: The ADVIA Centaur Vitamin D Total assay is a one… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2016 | Class II | Z-0398-2017 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Nonconforming Material/Component | Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K133156 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K021163.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MRG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRG
120in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRG
29in 2025
MAUDE reports naming product code MRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 227 | 0 | 1 |
| 2012 | 3 | 122 | 3 | 23 |
| 2013 | 7 | 231 | 1 | 21 |
| 2014 | 6 | 159 | 0 | 14 |
| 2015 | 3 | 264 | 0 | 18 |
| 2016 | 3 | 147 | 2 | 14 |
| 2017 | 3 | 120 | 0 | 21 |
| 2018 | 2 | — | 2 | 75 |
| 2019 | 1 | — | 0 | 38 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 2 | — | 0 | 22 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 2 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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®…
Read the full statement (143 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110586 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110586: Advia Centaur Vitamin D Total Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110586
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026