510(k) · Cleared
ClearedElecsys Progesterone 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 Oct 2, 2015 as substantially equivalent to K964841 (Boehringer Mannheim Corp., 1997) after a 29-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Oct 2, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964841 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964841 Elecsys Progesterone AssayBoehringer Mannheim Corp. · 1997
- This deviceK152526 Elecsys Progesterone III CalSetRoche Diagnostics · 2015
- Descendant · cites it directly · 0 of its ownK163546 Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc. · 2017
- Descendant · cites it directly · 0 of its ownK160729 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics · 2016 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964841 | Elecsys Progesterone Assay | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | 2015 | — |
| +1 | K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017 | — |
| +1 | K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 | Roche Diagnostics | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K964841 | Elecsys Progesterone AssaySummary page 6…analyzers. Predicate The Elecsys Progesterone III CalSet is substantially equivalent to the device predicate device, Elecsys Progesterone II CalSet (K964841). Substantial The following table compare the Elecsys Progesterone III CalSet with the Equivalence predicate device. Co… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K163546 (Fujirebio Diagnostics,Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Progesterone 111 CalSet is used for calibrating the quantitative Elecsys Progesterone 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/K152526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152526: Elecsys Progesterone 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/K152526
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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