510(k) · Cleared
Recalled · Class II · 2018Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, 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 Feb 8, 2017 as substantially equivalent to K113546 (Roche Diagnostics, 2012) after a 120-day review. Its family tree reaches back 8 generations to 1993. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 8, 2017
- Review
- 120 days
- Class
- Class II
- Product code
- MRG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931172 (1993). 26 ancestors in all, the oldest K900779 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 7 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 6 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 5 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 4 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 3 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 2 generations backK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
- 1 generation backK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
- This deviceK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017
- Descendant · cites it directly · 1 of its ownK210901 Elecsys Vitamin D total IIIRoche Diagnostics · 2021
- Descendant · 2 generations on · 0 of its ownK221817 ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., · 2023
- Descendant · cites it directly · 0 of its ownK170938 CalSet IGF-1Roche Diagnostics · 2017
- Descendant · cites it directly · 0 of its ownK170678 Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
Most influential descendants
Showing 4 of 4 · See all- K210901Elecsys Vitamin D total IIIRoche Diagnostics · 2021 · cites it directly1descendant
- K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., · 2023 · 2 generations on0descendants
- K170938CalSet IGF-1Roche Diagnostics · 2017 · cites it directly0descendants
- K170678Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −7 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −6 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −4 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −3 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −2 | K102157 | Elecsys Precicontrol Multimarker | Roche Diagnostics | 2010 | — |
| −1 | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3… | Roche Diagnostics | 2012 | — |
| 0 (this device) | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D… | Roche Diagnostics | 2017 | — |
| +1 | K210901 | Elecsys Vitamin D total III | Roche Diagnostics | 2021 | — |
| +2 | K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | 2023 | — |
| +1 | K170938 | CalSet IGF-1 | Roche Diagnostics | 2017 | — |
| +1 | K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | 2017 | — |
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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K113546 | Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Summary page 5…2- JIT, 862.1150 Regulation Numbers 3- JJX, 862.1660 4- JJX, 862.1660 Predicate Devices Elecsys Vitamin D Assay (k113546) For the Elecsys Vitamin D total II, the establishment registration numbers:… | 2012 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Apr 27, 2018 | Class II | Z-2389-2018 | Under Investigation by firm | The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a… |
| Apr 27, 2018 | Class II | Z-2390-2018 | Under Investigation by firm | The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K210901 (Roche Diagnostics, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K113546.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This 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 the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative…
Read the full statement (162 words)
Elecsys Vitamin D total II
The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This 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 the cobas e 411 immunoassay analyzer.
CalSet Vitamin D total II
CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer.
PreciControl Vitamin D total II
PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer.
CalCheck Vitamin D total II
This CalCheck set 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 total II reagent on the cobas e 411 immunoassay analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162840
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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