# K191499: MAGLUMI 2000 25-OH Vitamin D

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Decided: Aug 1, 2019 after 56 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: 3 generations back to K032844 (2004). 3 ancestors in all.
1 later device descends 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)
- K112725: Liaison 25 OH Vitamin D Total Assay, DiaSorin, Inc. (2012) Summary page 4.

## Most influential descendants
- K232587: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (2024), 0 descendants of its own

## Indications for use
MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.

Source page: https://510kreport.com/device/K191499
Methodology: https://510kreport.com/methodology