510(k) · Cleared
ClearedIDS Cortisol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems, Ltd. · CGR Radioimmunoassay, Cortisol
Cleared on Apr 13, 2021 as substantially equivalent to K152227 (Roche Diagnostics, 2016) after a 256-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Apr 13, 2021
- Review
- 256 days
- Class
- Class II
- Product code
- CGR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011323 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK011323 High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001
- 3 generations backK043175 Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. · 2004 · Recalled
- 2 generations backK070788 Elecsys Cortisol Test SystemRoche Diagnostics · 2007
- 1 generation backK152227 Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics · 2016
- This deviceK202136 IDS CortisolImmunodiagnostic Systems, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 | Salimetrics, LLC | 2001 | — |
| −3 | K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample Type | Roche Diagnostics Corp. | 2004 | 1 |
| −2 | K070788 | Elecsys Cortisol Test System | Roche Diagnostics | 2007 | — |
| −1 | K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016 | — |
| 0 (this device) | K202136 | IDS Cortisol | Immunodiagnostic Systems, Ltd. | 2021 | — |
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 CGR? 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 CGR device
- #1 K242190 Access Cortisol; DxC 500i Clinical Analyzerscore 7.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K152227 | Elecsys Cortisol II, Cortisol II CalSet | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All CGR devicesCGR Radioimmunoassay, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CGR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGR
113in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGR
1in 2018
MAUDE reports naming product code CGR, 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 | — | 1 | 1 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 3 | 113 | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IDS Cortisol assay is an in vitro diagnostic device intended for the quantitative determination of cortisol in human serum and plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.
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/K202136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202136: IDS Cortisol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202136
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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