510(k) · Cleared
ClearedElecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CDD Radioassay, Vitamin B12
Cleared on Sep 24, 2015 as substantially equivalent to K060755 (Roche Diagnostics Corp., 2006) after an 85-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Sep 24, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924862 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 3 generations backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- 2 generations backK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
- 1 generation backK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- This deviceK151786 Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetRoche Diagnostics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −3 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| −2 | K974383 | Elecsys Calcheck Vitamin B12 | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | Roche Diagnostics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 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 CDD? 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 CDD device
- #1 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckSummary page 5…ibrator 1. CDD, 862.1810 Product Codes 2. JIT, 862.1150 Predicate Devices Elecsys Vitamin B12 Assay (k060755) Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 Establishment Registration Roche Diagnost… | 2006 |
| † | K973702 | Elecsys Vitamin B12 Assay | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K060755.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · CDD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDD
147in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDD
44in 2025
MAUDE reports naming product code CDD, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 36 |
| 2012 | 3 | 147 | 0 | 23 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 2 | 15 |
| 2019 | 2 | — | 1 | 14 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 28 |
| 2022 | 1 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Vitamin B12 II CalSet is used for calibrating the quantitative Elecsys Vitamin B12 II assay on the Elecsys and cobas e immunoassay analyzers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151786: Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151786
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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