# K151786: Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 24, 2015 after 85 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: 4 generations back to K924862 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck, Roche Diagnostics Corp. (2006) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K151786
Methodology: https://510kreport.com/methodology