510(k) · Cleared
ClearedElecsys TSH Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Jul 22, 1996 as substantially equivalent to K915195 (Boehringer Mannheim Corp., 1992) after a 95-day review. Its family tree reaches back 1 generation to 1992. 7 later devices descend from it.
- Decided
- Jul 22, 1996
- Review
- 95 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915195 (1992). 7 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK915195 Enzymun-Test TSHBoehringer Mannheim Corp. · 1992
- This deviceK961491 Elecsys TSH AssayBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 2 of its ownK962573 Elecsys Precicontrol TSHBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 1 of its ownK162606 Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK060754 Elecsys TSH Calset W/Models 04738551Roche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK223690 iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash…Shenzhen Yhlo Biotech Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK140534 Elecsys Precicontrol TSRoche Diagnostics · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K962573Elecsys Precicontrol TSHBoehringer Mannheim Corp. · 1996 · cites it directly2descendants
- K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics · 2017 · cites it directly1descendant
- K060754Elecsys TSH Calset W/Models 04738551Roche Diagnostics Corp. · 2006 · cites it directly1descendant
- K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd. · 2023 · 2 generations on0descendants
- K140534Elecsys Precicontrol TSRoche Diagnostics · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915195 | Enzymun-Test TSH | Boehringer Mannheim Corp. | 1992 | — |
| 0 (this device) | K961491 | Elecsys TSH Assay | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K962573 | Elecsys Precicontrol TSH | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | 2017 | 3 |
| +1 | K060754 | Elecsys TSH Calset W/Models 04738551 | Roche Diagnostics Corp. | 2006 | — |
| +2 | K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | 2023 | — |
| +2 | K140534 | Elecsys Precicontrol TS | Roche Diagnostics | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K915195 | Enzymun-Test TSHSummary page 1…assay for the thyroid stimulating hormone. Classification name: Radioimmunoassay-thyroid stimulating hormone We claim substantial equivalence t¢ the Enzymun-Test® TSH (K915195). Continued on next page page 25 Diagnostics E Q Bl I e 510(k) Summary, Continued 4. Device Description 5.… | 1992 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962573 | Elecsys Precicontrol TSH | 1996 | 2 |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | 2017 | 1 |
| K060754 | Elecsys TSH Calset W/Models 04738551 | 2006 | 1 |
| K130469 | Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control… | 2013 | 0 |
| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay System | 2006 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K962573 (Boehringer Mannheim Corp., 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Immunoassay for the in vitro quantitative determination of Thyroid Stimulating Hormone in human serum and plasma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961491 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961491: Elecsys TSH Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961491
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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