510(k) · Cleared
ClearedElecsys Cortisol II, Cortisol II CalSet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JFT Fluorometric, Cortisol
Cleared on Apr 27, 2016 as substantially equivalent to K070788 (Roche Diagnostics, 2007) after a 264-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Apr 27, 2016
- Review
- 264 days
- Class
- Class II
- Product code
- JFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011323 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011323 High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001
- 2 generations backK043175 Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. · 2004 · Recalled
- 1 generation backK070788 Elecsys Cortisol Test SystemRoche Diagnostics · 2007
- This deviceK152227 Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics · 2016
- Descendant · cites it directly · 0 of its ownK202136 IDS CortisolImmunodiagnostic Systems, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202136IDS CortisolImmunodiagnostic Systems, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 | Salimetrics, LLC | 2001 | — |
| −2 | K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample Type | Roche Diagnostics Corp. | 2004 | 1 |
| −1 | K070788 | Elecsys Cortisol Test System | Roche Diagnostics | 2007 | — |
| 0 (this device) | K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016 | — |
| +1 | K202136 | IDS Cortisol | Immunodiagnostic Systems, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 JFT? 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 JFT device
- #1 K242505 Elecsys Cortisol IIIscore 10.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K070788 | Elecsys Cortisol Test SystemSummary page 5…, calibrator 1) JFT, 862.1205 Product Codes 2) JIT, 862.1150 Elecsys Cortisol (k070788) Predicate Devices Elecsys Cortisol CalSet (k070788) Roche Diagnostics… | 2007 |
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 |
|---|---|---|---|
| K202136 | IDS Cortisol | 2021 | 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 15 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K202136 (Immunodiagnostic Systems, Ltd., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JFT devicesJFT Fluorometric, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JFT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFT
Too few JFT 510(k)s in any year since 2007 to give a median.
Recalls per year · JFT
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFT
9in 2025
MAUDE reports naming product code JFT, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 16 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of cortisol in human serum, and plasma. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Cortisol II CalSet is used for calibrating the quantitative Elecsys Cortisol II 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/K152227 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152227: Elecsys Cortisol II, Cortisol II CalSet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152227
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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