# K091849: Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Inc.
- Decided: Jun 25, 2010 after 368 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
No predicates in its family tree.
4 later devices descend from it; 3 cite 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140554: Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control Set (2014), 1 descendant of its own
- K161831: IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (2016), 0 descendants of its own
- K142994: IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (2015), 0 descendants of its own
- K121608: Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total Calibrators (2013), 0 descendants of its own

## Indications for use
The IDS-iSYS Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin 0 (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population. The kit is for in vitro diagnostic use only. the IDS-iSYS 25-Hydroxy Vitamin D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the IDS-iSYS 25-Hydroxy Vitamin 0 Assay.

Source page: https://510kreport.com/device/K091849
Methodology: https://510kreport.com/methodology