# K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Dec 10, 2014 after 190 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: 3 generations back to K954418 (1995). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014030: 1,25-Dihydroxyvitamin D125I Ria, DiaSorin, Inc. (2002) Summary page 4.
- K132515: Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers, DiaSorin, Inc. (2013) Summary page 5.

## Most influential descendants
- K182698: LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device (2018), 1 descendant of its own
- K213858: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (2022), 0 descendants of its own
- K173683: LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers (2018), 0 descendants of its own

## Indications for use
The LIAISON® XL 1,25 Dihydroxyvitamin D is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 1,25 dihydroxyvitamin (1,25(OH)2D) in serum, EDTA and Lithium Heparin plasma. Results of the 1,25 Dihydroxyvitamin D are 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 adult populations. The test is to be performed on the LIAISON® XL Analyzer. The LIAISON® XL 1,25 Dihydroxyvitamin D Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL 1,25 Dihydroxyvitamin D assay. The LIAISON® XL 1,25 Dihydroxyvitamin D Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® XL1,25 Dihydroxyvitamin D assay.

Source page: https://510kreport.com/device/K141463
Methodology: https://510kreport.com/methodology