# K162298: LOCI Total Vitamin D Total Assay, LOCI VITD CAL

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 16, 2017 after 212 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: 4 generations back to K950469 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110586: Advia Centaur Vitamin D Total Assay, Siemens Healthcare Diagnostics, Inc. (2011) Summary page 5.

## Indications for use
The LOCI Vitamin D Total assay is an in vitro diagnostic test for the quantitative measurement of total 25(OH)vitamin D in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of vitamin D are used in the assessment of vitamin D sufficiency. The LOCI VITD CAL is an in vitro diagnostic product for the calibration of the Vitamin D (VITD) Total assay on the Dimension® EXL™ integrated chemistry system with LOCI® module.

Source page: https://510kreport.com/device/K162298
Methodology: https://510kreport.com/methodology