# K162698: MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Decided: Jul 14, 2017 after 290 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902336 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083844: Advia Centaur TSH3-Ultra Method, Siemens Healthcare Diagnostics (2009) Summary page 5.
- K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System, Siemens Healthcare Diagnostics, Inc. (2015) Summary page 5.

## 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
The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders. The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system’s assay application utilizes chemiluminescents technology for clinical use.

Source page: https://510kreport.com/device/K162698
Methodology: https://510kreport.com/methodology