# K182423: Maglumi 2000 FT4

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Decided: Oct 4, 2018 after 28 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- 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 K961510 (1996). 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)
- K080167: Acs 180 and Advia Centaur FT4 Immunoassays, Siemens Healthcare Diagnostics (2008) Summary page 4.

## Indications for use
The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.

Source page: https://510kreport.com/device/K182423
Methodology: https://510kreport.com/methodology