510(k) · Cleared
Recalled · Class II · 2017ADVIA Centaur TSH3-Ultra
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 May 1, 2015 as substantially equivalent to K083844 (Siemens Healthcare Diagnostics, 2009) after a 72-day review. Its family tree reaches back 1 generation to 2009. 7 later devices descend from it. It has been recalled once.
- Decided
- May 1, 2015
- Review
- 72 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083844 (2009). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK083844 Advia Centaur TSH3-Ultra MethodSiemens Healthcare Diagnostics · 2009 · Recalled
- This deviceK150403 ADVIA Centaur TSH3-UltraSiemens Healthcare Diagnostics, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK233050 ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK162698 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK251543 Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK232587 MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence…Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly4descendants
- K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2024 · cites it directly1descendant
- K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2017 · 2 generations on1descendant
- K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc. · 2026 · 2 generations on0descendants
- K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083844 | Advia Centaur TSH3-Ultra Method | Siemens Healthcare Diagnostics | 2009 | 4 |
| 0 (this device) | K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +1 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH… | Siemens Healthcare Diagnostics, Inc. | 2015 | 22 |
| +1 | K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
| +2 | K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017 | — |
| +2 | K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
| +3 | K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay… | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
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 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)score 11.4 · 3 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 |
|---|---|---|---|
| * | K083844 | Advia Centaur TSH3-Ultra MethodSummary page 4…the ADVIA Centaur TSH3-Ultra assay does not require any other device modifications (i.e. no change to design or manufacturing process). Therefore, the predicate device (K083844) and subject device are the same. Siemens Healthcare Diagnostics Inc., Tarrytown, NY Page 1 of 4… | 2009 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2017 | Class II | Z-2054-2018 | Device Design | 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 TSH3RUL Assays. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150403: ADVIA Centaur TSH3-Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150403
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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