# K153361: Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Apr 15, 2016 after 147 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: 2 generations back to K032844 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602, DiaSorin, Inc. (2007) Summary page 4.

## Indications for use
Lumipulse G 25-0H Vitamin D For in vitro diagnostic use. Lumipulse G 25-0H Vitamin D is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of25-hydroxyvitamin D (25-0H vitamin D) and other hydroxylated vitamin D metabolites in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System. Lumipulse G 25-0H Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. Lumipulse G 25-0H Vitamin D Calibrators Lumipulse G 25-0H Vitamin D Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G 25-0H Vitamin D on the LUMIPULSE G System.

Source page: https://510kreport.com/device/K153361
Methodology: https://510kreport.com/methodology