510(k) · Cleared
ClearedElecsys Estradiol III CalSet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JIT Calibrator, Secondary
Cleared on Aug 12, 2014 as substantially equivalent to K992981 (Roche Diagnostics Corp., 1999) after an 18-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Aug 12, 2014
- Review
- 18 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K965109 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK965109 Elecsys Estradiol AssayBoehringer Mannheim Corp. · 1997
- 1 generation backK992981 Elecsys Estradiol Calset IIRoche Diagnostics Corp. · 1999
- This deviceK142021 Elecsys Estradiol III CalSetRoche Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK163053 Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K163053Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965109 | Elecsys Estradiol Assay | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K992981 | Elecsys Estradiol Calset II | Roche Diagnostics Corp. | 1999 | — |
| 0 (this device) | K142021 | Elecsys Estradiol III CalSet | Roche Diagnostics | 2014 | — |
| +1 | K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K992981 | Elecsys Estradiol Calset IISummary page 2…on the Elecsys and cobas e immunoassay analyzers. The Elecsys Estradiol I1I CalSet is substantially equivalent to the predicate device, Elecsys Estradiol II CalSet I1 (K992981). The following tables compare the Elecsys Estradiol 111 CalSet with the predicate device. Continued on next page === Page 3 =… | 1999 |
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 |
|---|---|---|---|
| K163053 | Lumipulse G E2-III Calibrators | 2016 | 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 17 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K163053 (Fujirebio Diagnostics,Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K992981.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Estradiol III CalSet is used for calibrating the quantitative Elecsys Estradiol III assay on the Elecsys and cobas e immunoassay analyzers.
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/K142021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142021: Elecsys Estradiol III CalSet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142021
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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