# K032844: Liaison 25 OH Vitamin D

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Feb 12, 2004 after 154 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DiaSorin 25-Hydroxyvitamin D 125I RIA: named in the summary without a submission number

## Most influential descendants
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602 (2007), 24 descendants of its own
- 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

## Recalls of this device
- Dec 5, 2008 · Not classified · Z-1042-2009: DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer.
- Feb 1, 2008 · Not classified · Z-1240-2008: Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
- Feb 14, 2005 · Not classified · Z-0638-05: An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrat
- Feb 14, 2005 · Not classified · Z-0637-05: Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the rever

## Indications for use
The LIAISON® Control 25 OH Vitamin D Set is intended for use as assayed quality control materials to monitor the accuracy and precision of the LIAISON® 25 OH Vitamin D immunoassay. This kit is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.

Source page: https://510kreport.com/device/K032844
Methodology: https://510kreport.com/methodology