510(k) · Cleared
ClearedAtellica® IM TSH3-Ultra II (TSH3ULII)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Feb 6, 2026 as substantially equivalent to K233050 (Siemens Healthcare Diagnostics, Inc., 2024) after a 262-day review. Its family tree reaches back 3 generations to 2009.
- Decided
- Feb 6, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K083844 (2009). No later device cites it as a predicate yet.
- Root · 3 generations backK083844 Advia Centaur TSH3-Ultra MethodSiemens Healthcare Diagnostics · 2009 · Recalled
- 2 generations backK150403 ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- 1 generation backK233050 ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2024
- This deviceK251543 Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K083844 | Advia Centaur TSH3-Ultra Method | Siemens Healthcare Diagnostics | 2009 | 4 |
| −2 | K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. | 2015 | 1 |
| −1 | K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
| 0 (this device) | K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JLW device
- #1 K233050 ADVIA Centaur® TSH3-Ultra II (TSH3ULII)score 10.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Summary page 5…evice The predicate device, ADVIA Centaur® TSH3-Ultra II (TSH3ULII) manufactured by Siemens Healthcare Diagnostics, Inc, Tarrytown, NY USA, was cleared by the FDA under K233050. 4. Device Description This assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to pa… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · JLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JLW
194in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JLW
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLW
103in 2025
MAUDE reports naming product code JLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 19 |
| 2008 | 5 | 143 | 0 | 10 |
| 2009 | 2 | — | 0 | 41 |
| 2010 | 1 | — | 1 | 34 |
| 2011 | 0 | — | 1 | 167 |
| 2012 | 1 | — | 3 | 144 |
| 2013 | 1 | — | 0 | 168 |
| 2014 | 1 | — | 0 | 155 |
| 2015 | 3 | 142 | 0 | 203 |
| 2016 | 3 | 238 | 1 | 183 |
| 2017 | 4 | 194 | 0 | 235 |
| 2018 | 0 | — | 4 | 249 |
| 2019 | 1 | — | 1 | 216 |
| 2020 | 0 | — | 2 | 145 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 1 | — | 0 | 137 |
| 2023 | 1 | — | 0 | 162 |
| 2024 | 2 | — | 2 | 169 |
| 2025 | 1 | — | 2 | 103 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251543: Atellica® IM TSH3-Ultra II (TSH3ULII).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251543
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026