# K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 13, 2007 after 195 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902336 (1990). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer, Bayer Healthcare, LLC (2004) Summary page 1.
- K010050: Advia Centaur and Acs: 180 Folate Immunoassay, Bayer Diagnostics Corp. (2001) Summary page 1.
- K983548: Ferritin Calibrator, Dade Behring, Inc. (1998) Summary page 1.

## Most influential descendants
- K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator (2012), 1 descendant of its own
- K133512: Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal) (2014), 0 descendants of its own
- K093645: Exl Anem Cal, Model RC640 (2010), 0 descendants of its own
- K093631: B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644 (2010), 0 descendants of its own

## Recalls of this device
- May 8, 2012 · Class II · Z-1869-2012: Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of V

## Indications for use
The B12 Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The FOL Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of megaloblastic anemia. The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of Ferritin (FERR), Vitamin B 12 (B12), and Folate (FOL) methods on the Dimension Vista® system.

Source page: https://510kreport.com/device/K071224
Methodology: https://510kreport.com/methodology