# K150403: ADVIA Centaur TSH3-Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 1, 2015 after 72 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K083844 (2009). 1 ancestor in all.
7 later devices descend from it; 2 cite 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 4.

## Most influential descendants
- K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (2015), 4 descendants of its own
- K233050: ADVIA Centaur®  TSH3-Ultra II (TSH3ULII) (2024), 1 descendant of its own
- K162698: MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (2017), 1 descendant of its own
- K251543: Atellica® IM TSH3-Ultra II (TSH3ULII) (2026), 0 descendants of its own
- K232587: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (2024), 0 descendants of its own

## Recalls of this device
- Dec 18, 2017 · Class II · Z-2054-2018: In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3R

## Indications for use
For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum, heparinized plasma, and EDTA plasma using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K150403
Methodology: https://510kreport.com/methodology