510(k) · Cleared
Recalled · 2007Elecsys Cortisol Test System, Addition of Saliva Sample Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NHG Enzyme Immunoassay, Cortisol, Salivary
Cleared on Nov 24, 2004 as substantially equivalent to K011323 (Salimetrics, LLC, 2001) after an 8-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 24, 2004
- Review
- 8 days
- Class
- Class II
- Product code
- NHG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011323 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011323 High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001
- This deviceK043175 Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. · 2004
- Descendant · cites it directly · 2 of its ownK070788 Elecsys Cortisol Test SystemRoche Diagnostics · 2007
- Descendant · 2 generations on · 1 of its ownK152227 Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics · 2016
- Descendant · 3 generations on · 0 of its ownK202136 IDS CortisolImmunodiagnostic Systems, Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 | Salimetrics, LLC | 2001 | — |
| 0 (this device) | K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample Type | Roche Diagnostics Corp. | 2004 | — |
| +1 | K070788 | Elecsys Cortisol Test System | Roche Diagnostics | 2007 | — |
| +2 | K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016 | — |
| +3 | K202136 | IDS Cortisol | Immunodiagnostic Systems, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Summary page 2…marketed in the United States. We claim equivalence to the Salimetrics HS (high sensitivity) Salivary Cortisol Enzyme cleared under K01 1323. Both products are intended for use in the quantitative determination of cortisol in human saliva. Substanti… | 2001 |
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 |
|---|---|---|---|
| K070788 | Elecsys Cortisol Test System | 2007 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2007 | Not classified | Z-0977-2007 | Other | The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NHG devicesNHG Enzyme Immunoassay, Cortisol, Salivary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Elecsys Cortisol is an immunoassay for the in-vitro quantitative determination of cortisol in 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 the Roche Elecsys 101012010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043175: Elecsys Cortisol Test System, Addition of Saliva Sample Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043175
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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