510(k) · Cleared
ClearedElecsys Cortisol Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · NHG Enzyme Immunoassay, Cortisol, Salivary
Cleared on Oct 5, 2007 as substantially equivalent to K043175 (Roche Diagnostics Corp., 2004) after a 197-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 5, 2007
- Review
- 197 days
- Class
- Class II
- Product code
- NHG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011323 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011323 High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001
- 1 generation backK043175 Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. · 2004 · Recalled
- This deviceK070788 Elecsys Cortisol Test SystemRoche Diagnostics · 2007
- Descendant · cites it directly · 1 of its ownK152227 Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics · 2016
- Descendant · 2 generations on · 0 of its ownK202136 IDS CortisolImmunodiagnostic Systems, Ltd. · 2021
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 |
|---|---|---|---|---|---|
| −2 | K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 | Salimetrics, LLC | 2001 | — |
| −1 | K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample Type | Roche Diagnostics Corp. | 2004 | 1 |
| 0 (this device) | K070788 | Elecsys Cortisol Test System | Roche Diagnostics | 2007 | — |
| +1 | K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016 | — |
| +2 | K202136 | IDS Cortisol | Immunodiagnostic Systems, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 NHG? 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 |
|---|---|---|---|
| * | K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample TypeSummary page 2…gally marketed in the United States. The Elecsys Cortisol Test System (modified) is equivalent to the Elecsys Cortisol Test System (K043175). Device The following table compares the Elecsys Cortisol Test System (modified) Comparison and the predic… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152227 | Elecsys Cortisol II, Cortisol II CalSet | 2016 | 1 |
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 6 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K152227 (Roche Diagnostics, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NHG devicesNHG Enzyme Immunoassay, Cortisol, Salivary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NHG
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NHG
Too few NHG 510(k)s in any year since 2007 to give a median.
Recalls per year · NHG
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHG
1in 2024
MAUDE reports naming product code NHG, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 3 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Eleesys Cortisol Immunoassay
Immunoassay for the in vitro quantitative determination of cortisol in human serum, plasma, urine, and saliva. 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.
Eleesys Cortisol CalSet
Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys Cortisol assay on the Elecsys immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070788: Elecsys Cortisol Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070788
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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