# K093631: B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Feb 12, 2010 after 80 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator, Dade Behring, Inc. (2007) Summary page 1.

## Indications for use
The B12 Flex® reagent cartridge is an in vitro product for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension® EXLTM integrated chemistry system. Measurements of vitamin B12 are used in the diagnosis and treatnient of anemias of the gastrointestinal malabsorption. The FOL Flex® reagent cartridge is an in vitro product for the quantitative measurement of Folate in human serum on the Dimension® EXL" integrated chemistry system. Measurements of folate are used in the diagnosis and treatment of megaloblastic anemia

Source page: https://510kreport.com/device/K093631
Methodology: https://510kreport.com/methodology