# K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Oct 1, 2007 after 125 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: 1 generation back to K032844 (2004). 1 ancestor in all.
24 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032844: Liaison 25 OH Vitamin D, DiaSorin, Inc. (2004) Summary page 1.

## Most influential descendants
- K110619: Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls (2011), 11 descendants of its own
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 descendants of its own
- K112725: Liaison 25 OH Vitamin D Total Assay (2012), 8 descendants of its own
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (2017), 4 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 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 hydroxylated vitamin D metabolites in human serum, EDTA-plasma or lithium heparin plasma to be used in the assessment of vitamin D 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. The LIAISON® 25 OH Vitamin D TOTAL Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 OH Vitamin D TOTAL Assay. The LIAISON® 25 OH Vitamin D TOTAL Specimen Diluent Set may be used to dilute specimens with values greater that 150 ng/mL by the LIAISON® 25 OH Vitamin D TOTAL Assay.

Source page: https://510kreport.com/device/K071480
Methodology: https://510kreport.com/methodology