# K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Nov 30, 2012 after 147 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: 5 generations back to K902336 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 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 1.
- K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator, Dade Behring, Inc. (2007) Summary page 1.

## Most influential descendants
- K133512: Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal) (2014), 0 descendants of its own

## Indications for use
The VB12 method is an in vitro diagnostic test for the quantitative measurement of vitamin B12 in human serum and plasma on the Dimension Vista® System. Measurements of vitamin B12 are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The LOCI 4 CAL is an in vitro diagnostic product for the calibration of LOCI Ferritin (FERR), LOCI Folate (FOL), and LOCI Vitamin B12 (VB12) methods on the Dimension Vista® System.

Source page: https://510kreport.com/device/K121994
Methodology: https://510kreport.com/methodology