# K133512: Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jan 2, 2014 after 48 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: 6 generations back to K902336 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator, Siemens Healthcare Diagnostics, Inc. (2012) Summary page 1.

## Indications for use
The VB12 method is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 (B12) in human serum and plasma on the Dimension EXL with LM integrated chemistry system. Measurements of Vitamin B12 may be used in the diagnosis of vitamin B12 deficiency. The LOCI ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI FOLA and LOCI VB12 assays on the Dimension EXL with LM integrated chemistry system.

Source page: https://510kreport.com/device/K133512
Methodology: https://510kreport.com/methodology