# K112725: Liaison 25 OH Vitamin D Total Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jan 20, 2012 after 122 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K032844 (2004). 2 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602, DiaSorin, Inc. (2007) Summary page 1.

## Most influential descendants
- K191499: MAGLUMI 2000 25-OH Vitamin D (2019), 1 descendant of its own
- K142373: Access 25(OH) Vitamin  D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst (2014), 1 descendant of its own
- K232587: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (2024), 0 descendants of its own
- K223503: Access 25(OH) Vitamin D Total (2023), 0 descendants of its own
- K142362: Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. (2014), 0 descendants of its own

## Indications for use
The LIAISON" 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of 25-hydroxyvitamin D and other hydraxylated vitamin 0 metabolites in human serum to be used in the assessment of vitamin 0 sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.

Source page: https://510kreport.com/device/K112725
Methodology: https://510kreport.com/methodology