510(k) · Cleared
ClearedLiaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control Thyroid 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Apr 5, 2013 as substantially equivalent to K961491 (Boehringer Mannheim Corp., 1996) and 1 other predicate after a 39-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Apr 5, 2013
- Review
- 39 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931172 (1993). 11 ancestors in all, the oldest K915195 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 7 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 6 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 5 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 4 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 3 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 2 generations backK051687 Elecsys Precicontrol UniversalRoche Diagnostics Corp. · 2005
- 1 generation backK090541 Elecsys Precicontrol UniversalRoche Diagnostics · 2009
- This deviceK130469 Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2…DiaSorin, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −7 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −6 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −4 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −3 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −2 | K051687 | Elecsys Precicontrol Universal | Roche Diagnostics Corp. | 2005 | — |
| −1 | K090541 | Elecsys Precicontrol Universal | Roche Diagnostics | 2009 | — |
| 0 (this device) | K130469 | Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison… | DiaSorin, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 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? (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 |
|---|---|---|---|
| * | K961491 | Elecsys TSH AssaySummary page 1…JLW, J.JX PREDICATE DEV ICE: Roche Elecsys® TSH Assay Reference K961491 (Assay) Elecsys® PreciControl Universal… | 1996 |
| * | K090541 | Elecsys Precicontrol UniversalSummary page 1…Reference K961491 (Assay) Elecsys® PreciControl Universal Reference K090541 (Controls) DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay for th… | 2009 |
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 20 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 11 ancestors has a recall.
- 4 other devices also cite its predicate K961491.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay intended for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON®XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130469: Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control Thyroid 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130469
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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