510(k) · Cleared
ClearedElecsys Progesterone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JLS Radioimmunoassay, Progesterone
Cleared on Mar 24, 1997 after a 111-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Mar 24, 1997
- Review
- 111 days
- Class
- Class I
- Product code
- JLS
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 1 citing it directly.
- This deviceK964841 Elecsys Progesterone AssayBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 2 of its ownK152526 Elecsys Progesterone III CalSetRoche Diagnostics · 2015
- Descendant · 2 generations on · 0 of its ownK163546 Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK160729 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics · 2016 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K152526Elecsys Progesterone III CalSetRoche Diagnostics · 2015 · cites it directly2descendants
- K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc. · 2017 · 2 generations on0descendants
- K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964841 | Elecsys Progesterone Assay | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | 2015 | — |
| +2 | K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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 JLS? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K931117 | FDA’s K931117 is Assess (TM) Low Abnormal Control Our OCR of the scanned summary read K931117, FDA’s number for Assess (TM) Low Abnormal Control (Instrumentation Laboratory CO). Its FDA name has none of the distinctive words the summary uses for the device it names, “Enzymun-Test® Progesterone Assay”. Kept off the family tree. Summary page 1…cence assay for the determination of progesterone. Classification name: System, Test, Progesterone We claim substantial equivalence to the Enzymun® Progesterone Assay (K931117). - Continued on next page page 27 FP— 510(k) Summary, Continued 4. Competition principle. Total duration of… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152526 | Elecsys Progesterone III CalSet | 2015 | 2 |
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?
- Of its descendants, K152526 (Roche Diagnostics, 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JLS devicesJLS Radioimmunoassay, Progesterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JLS
FDA has decided no JLS device since 2007.
Median 510(k) review, days · JLS
Too few JLS 510(k)s in any year since 2007 to give a median.
Recalls per year · JLS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLS
3in 2025
MAUDE reports naming product code JLS, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 3 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 1 | 41 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of progesterone 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/K964841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964841: Elecsys Progesterone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964841
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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