# K251543: Atellica® IM TSH3-Ultra II (TSH3ULII)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 6, 2026 after 262 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: 3 generations back to K083844 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233050: ADVIA Centaur®  TSH3-Ultra II (TSH3ULII), Siemens Healthcare Diagnostics, Inc. (2024) Summary page 5.

## Indications for use
The Atellica® IM TSH3‑Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. 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/K251543
Methodology: https://510kreport.com/methodology