510(k) · Cleared
ClearedElecsys TSH Calset W/Models 04738551
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JIT Calibrator, Secondary
Cleared on Apr 18, 2006 as substantially equivalent to K961491 (Boehringer Mannheim Corp., 1996) after a 28-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Apr 18, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915195 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915195 Enzymun-Test TSHBoehringer Mannheim Corp. · 1992
- 1 generation backK961491 Elecsys TSH AssayBoehringer Mannheim Corp. · 1996
- This deviceK060754 Elecsys TSH Calset W/Models 04738551Roche Diagnostics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK062581 Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay…Olympus America, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062581Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemOlympus America, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915195 | Enzymun-Test TSH | Boehringer Mannheim Corp. | 1992 | — |
| −1 | K961491 | Elecsys TSH Assay | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K060754 | Elecsys TSH Calset W/Models 04738551 | Roche Diagnostics Corp. | 2006 | — |
| +1 | K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay System | Olympus America, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 JIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K961491 | Elecsys TSH AssaySummary page 2…cate The Elecsys TSH CalSet is equivalent to other devices legally marketed in the Device United States. We claim equivalence to the Elecsys TSH CalSet (K961491). Device The table below compares the device features of the Elecsys TSH CalSet Comparison (modified) and origi… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062581 (Olympus America, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K961491.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay
on the Elecsys immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060754: Elecsys TSH Calset W/Models 04738551.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060754
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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