# K192064: LIAISON Vitamin B12

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Oct 2, 2019 after 62 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 K925637 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140496: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents, Beckman Coulter, Inc. (2014) Summary page 4.

## Indications for use
The DiaSorin LIAISON® Vitamin B12 assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Vitamin B12 in human serum, SST serum and lithium heparin plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemia’s of gastrointestinal malabsorption. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The assay must be performed on the LIAISON® XL Analyzer.

Source page: https://510kreport.com/device/K192064
Methodology: https://510kreport.com/methodology