510(k) · Cleared
ClearedElecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · MRG System, Test, Vitamin D
Cleared on Jul 24, 2012 as substantially equivalent to K110619 (Biokit, S.A., 2011) and 3 other predicates after a 236-day review. Its family tree reaches back 7 generations to 1993. 8 later devices descend from it.
- Decided
- Jul 24, 2012
- Review
- 236 days
- Class
- Class II
- Product code
- MRG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K931172 (1993). 25 ancestors in all, the oldest K900779 (1990). 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 6 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 5 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 4 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 3 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 2 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 1 generation backK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
- This deviceK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- Descendant · cites it directly · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 2 generations on · 1 of its ownK210901 Elecsys Vitamin D total IIIRoche Diagnostics · 2021
- Descendant · 2 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
- Descendant · 3 generations on · 0 of its ownK221817 ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · cites it directly4descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · cites it directly2descendants
- K210901Elecsys Vitamin D total IIIRoche Diagnostics · 2021 · 2 generations on1descendant
- K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 2 generations on0descendants
- K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −6 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −3 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −2 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −1 | K102157 | Elecsys Precicontrol Multimarker | Roche Diagnostics | 2010 | — |
| 0 (this device) | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… | Roche Diagnostics | 2012 | — |
| +1 | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… | Roche Diagnostics | 2017 | 2 |
| +1 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +2 | K210901 | Elecsys Vitamin D total III | Roche Diagnostics | 2021 | — |
| +2 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
| +3 | K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K110619 | Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsSummary page 6…Device: Abbott Feature j Elecsys Vitamin D Assay Architect 25-OH Vitamin D j__________________________(K1 10619) General Assay Features Instrument Eleesys 2010 and cobas e 411 Abbott Archite… | 2011 |
| * | K103221 | Elecys HGH Calset, Elecsys HGH Calcheck 5Summary page 4…Vitamin D assay (KI 10619). (2) Elecsys Vitamin D CalSet is equivalent to the standards contained in the Elecsys hGH CalSet (K103221) (Human Growth Hormone). (3) Eleesys PreciControl Varia 3 is equivalent to the controls contained in… | 2010 |
| * | K102157 | Elecsys Precicontrol MultimarkerSummary page 4…Human Growth Hormone). (3) Eleesys PreciControl Varia 3 is equivalent to the controls contained in the PreciControl Multimarker (K102 157). (4) The Elecsys Vitamin DCalCheck 5 is equivalent to the Elecsys T4 CalCheck 5 (KI 125… | 2010 |
| * | K112528 | Elecsys T4 Calcheck 5Summary page 14…Eleesys Vitamin D CaiCheck 5 Predicate Device: Elecsys T4 CaiCheck 5 (K1 12528) Intended Use The Eleesys Vitamin D CalCheck 5 is an The Elecsys T4 CalCheck 5 is an assayed con… | 2011 |
What descends from it? (8)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K162840 (Roche Diagnostics, 2017) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K110619.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxy vitamin D in human serum and plasma. The Elecsys Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Eleesys Vitanmin D CalSet is used for calibrating the quantitative Eleesys Vitamin D assay on the Eleesys and…
Read the full statement (140 words)
The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxy vitamin D in human serum and plasma. The Elecsys Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults.
The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
Eleesys Vitanmin D CalSet is used for calibrating the quantitative Eleesys Vitamin D assay on the Eleesys and cobas e inmmnoassay analyzers.
Eleesys PreciControl Varia 3 is used for quality control of specified Elecsys inmmnoassays on Elecsys and cobas e inimunoassay analyzers.
The Eleosys Vitamin 0 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Eleosys and cobas e inmmoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113546 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113546
Report an extraction error
Are you the manufacturer?
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