# K083844: Advia Centaur TSH3-Ultra Method

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: May 8, 2009 after 135 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K150403: ADVIA Centaur TSH3-Ultra (2015), 7 descendants of its own
- 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

## Recalls of this device
- Apr 10, 2014 · Class II · Z-1654-2014: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
- Apr 10, 2014 · Class II · Z-1653-2014: Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
- May 10, 2013 · Class II · Z-1881-2013: A rare variant of TSH, identified in a small cluster of patients, is not detected.
- Jul 25, 2012 · Class II · Z-2313-2012: Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays

Source page: https://510kreport.com/device/K083844
Methodology: https://510kreport.com/methodology