| K-number | K242505 |
| Device name | Elecsys Cortisol III |
| Applicant | Roche Diagnostics |
| Product code | JFT |
| Device class | Class II |
| Decision date | Jul 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 862.1205 |
The Elecsys Cortisol III is an immunoassay for measuring cortisol levels in 24-hour human urine samples. It uses electrochemiluminescence detection on cobas e analyzers and is intended to help diagnose and treat functional disorders of the adrenal gland.
Elecsys Cortisol III uses electrochemiluminescence immunoassay (ECLIA) detection on cobas e analyzers with a urine sample type and reportable range of 0.725–18.1 μg/dL. The predicate ARCHITECT Cortisol uses chemiluminescent microparticle immunoassay (CMIA) on ARCHITECT i systems with serum, plasma, or urine samples and a reportable range of 0.8–59.8 μg/dL.
Testing followed CLSI standards including EP05-A3 (precision/reproducibility), EP17-A2 (analytical sensitivity limits), EP06-Ed2 (linearity), EP09-A3 (method comparison), and EP28-A3c (reference ranges).
Elecsys Cortisol III demonstrates substantial equivalence through equivalent intended use (urine cortisol measurement for adrenal disorder diagnosis/treatment), comparable analytical performance (precision CVs 2.0–3.2%, similar reportable ranges, no significant interference), and method comparison showing agreement with the predicate ARCHITECT Cortisol across the measuring range. Both detect cortisol via competitive immunoassay using monoclonal antibodies and are used in comparable clinical contexts, despite differences in detection chemistry and instrument platform.
View the full FDA submission: accessdata.fda.gov