510(k) · Cleared
ClearedElecsys Vitamin B12 Immunoassay, Calset II and Calcheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CDD Radioassay, Vitamin B12
Cleared on Apr 10, 2006 as substantially equivalent to K973702 (Boehringer Mannheim Corp., 1997) and 2 other predicates after a 20-day review. Its family tree reaches back 3 generations to 1992. 9 later devices descend from it.
- Decided
- Apr 10, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K924862 (1992). 6 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 2 generations backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- 1 generation backK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
- This deviceK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 3 of its ownK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK121994 Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension…Siemens Healthcare Diagnostics, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK110579 Architect B12 Reagents, Architect B12 Calibrators, and Architect B12…Abbott Laboratories · 2011
- Descendant · 3 generations on · 0 of its ownK191533 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly3descendants
- K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on2descendants
- K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc. · 2012 · cites it directly1descendant
- K110579Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsAbbott Laboratories · 2011 · cites it directly1descendant
- K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −2 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| −1 | K974383 | Elecsys Calcheck Vitamin B12 | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| +1 | K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)… | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +1 | K121994 | Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista… | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| +1 | K110579 | Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls | Abbott Laboratories | 2011 | — |
| +3 | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K973702 | Elecsys Vitamin B12 AssaySummary page 3…For the Vitamin B312 assay and the Vitamin B12 CalSet II: · The originalElecsys Vitamin B12on the Elecsys 2010was cleared under K973702. · 2001under K961481/A003, the MODULAR ANALYTICS E170 In analyzer… | 1997 |
| * | K961481 | Elecsys 2010 AnalyzerSummary page 3…tamin B12 CalSet II: · The originalElecsys Vitamin B12on the Elecsys 2010was cleared under K973702. · 2001under K961481/A003, the MODULAR ANALYTICS E170 In analyzer was acknowledged by FDA. For… | 1996 |
| * | K974383 | Elecsys Calcheck Vitamin B12Summary page 3…r was acknowledged by FDA. For the Vitamin B 12 CalCheck: · The original Elecsys Vitamin Bl2 CalCheck was cleared under K974383. 510(k) Summary - Elecsys Vitamin B12 Test System, Continued Device The table below compares the Elecs… | 1997 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and… | 2014 | 3 |
| K121994 | Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4… | 2012 | 1 |
| K110579 | Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls | 2011 | 1 |
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | 2015 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K140505 (Siemens Healthcare Diagnostics, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years.
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. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. A Vitamin B 12 test system is a device intended to measure Vitamin B12 in serum, plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal…
Read the full statement (121 words)
Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
A Vitamin B 12 test system is a device intended to measure Vitamin B12 in serum, plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 201 0 and MODULAR ANALYTICS El170 immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060755 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060755
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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