# K014030: 1,25-Dihydroxyvitamin D125I Ria

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Mar 26, 2002 after 110 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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 '*I RIA: named in the summary without a submission number

## Most influential descendants
- K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers (2014), 3 descendants of its own
- 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

## Recalls of this device
- Jun 5, 2006 · Not classified · Z-0707-2007: Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the

## Indications for use
The 1,25-Dihydroxyvitamin D '®I RIA is a competitive equilibrium radioimmunoassay intended for the quantitative determination of 1,25-dihydroxyvitamin D (1,25-(OH),-D) in human serum or EDTA plasma to be used to assess 1,25-(OH),-D deficiency associated with renal disease. Since hydroxylation of circulating 25-hydroxyvitamin D to the biologically active form 1,25-(OH),-D occurs in the kidney, renal disease may result in reduced levels of 1,25-(OH),-D and compromised calcium metabolic homeostasis. 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.

Source page: https://510kreport.com/device/K014030
Methodology: https://510kreport.com/methodology