# K232587: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Decided: Apr 12, 2024 after 231 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: 6 generations back to K902336 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191499: MAGLUMI 2000 25-OH Vitamin D, Shenzhen New Industries Biomedical Engineering Co., Ltd. (2019) Summary page 4.
- K162698: MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer, Shenzhen New Industries Biomedical Engineering Co., Ltd. (2017) Summary page 4.

## Indications for use
The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer, and the assay is used for an aid in assessment of vitamin D sufficiency.

Source page: https://510kreport.com/device/K232587
Methodology: https://510kreport.com/methodology