510(k) · Cleared
Recalled · Class II · 2017Advia Centaur TSH
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 Apr 22, 2015 as substantially equivalent to K910981 (Ciba Corning Diagnostics Corp., 1991) after a 273-day review. Its family tree reaches back 1 generation to 1991. It has been recalled 3 times.
- Decided
- Apr 22, 2015
- Review
- 273 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910981 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910981 Ciba Corning Acs TSH ImmunoassayCiba Corning Diagnostics Corp. · 1991
- This deviceK141999 Advia Centaur TSHSiemens Healthcare Diagnostics, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910981 | Ciba Corning Acs TSH Immunoassay | Ciba Corning Diagnostics Corp. | 1991 | — |
| 0 (this device) | K141999 | Advia Centaur TSH | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
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? (2)
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 |
|---|---|---|---|
| * | K910981 | Ciba Corning Acs TSH ImmunoassaySummary page 4…862.1690 4. Predicate Device Information The ADVIA Centaur TSH assay was originally cleared by the FDA on 04/30/1991 (k910981) as the ACS TSH Immunoassay. 5. Description of Device Modifications No changes were made to the ADVIA Centaur TSH… | 1991 |
| * | — | ADVIA Centaur XP system Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2017 | Class II | Z-1537-2017 | Under Investigation by firm | Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the… |
| May 26, 2016 | Class II | Z-2256-2016 | Under Investigation by firm | Eight (8) issues were identified which may affect the results generated by the system software version. |
| Apr 28, 2016 | Class II | Z-0072-2017 | Under Investigation by firm | The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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 using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT 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/K141999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141999: Advia Centaur TSH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141999
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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