# K140554: Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Dec 19, 2014 after 290 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 K091849 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091849: Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set, Immunodiagnostic Systems, Inc. (2010) Summary page 5.

## Most influential descendants
- K161831: IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (2016), 0 descendants of its own

## Indications for use
The IDS iSYS 25-Hydroxy Vitamin DS Assay (IDS-iSYS 25OHDS) is intended for the quantitative determination of 25-hydroxyvitamin D (25OHD) and other hydroxylated metabolites in human serum on the IDS iSYS Multi-Discipline Automated System. 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 IDS-iSYS 25-Hydroxy Vitamin DS (25OHDS) Control Set is used for quality control of the IDS-iSYS 25-Hydroxy Vitamin DS assay on the IDS-iSYS Multi-Discipline Automated System.

Source page: https://510kreport.com/device/K140554
Methodology: https://510kreport.com/methodology