# K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 10, 2006 after 20 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924862 (1992). 6 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973702: Elecsys Vitamin B12 Assay, Boehringer Mannheim Corp. (1997) Summary page 3.
- K961481: Elecsys 2010 Analyzer, Boehringer Mannheim Corp. (1996) Summary page 3.
- K974383: Elecsys Calcheck Vitamin B12, Boehringer Mannheim Corp. (1997) Summary page 3.

## Most influential descendants
- K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material (2014), 3 descendants of its own
- K151986: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (2016), 2 descendants of its own
- K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator (2012), 1 descendant of its own
- K110579: Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls (2011), 1 descendant of its own
- K191533: ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K060755
Methodology: https://510kreport.com/methodology