Identifiers
- 510(k) Number
- K021218 FDA 510(k)
- FDA Product Code
- JFT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1205 FDA 510(k)
- Regulation Number
- 862.1205 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys Cortisol Test System is an electrochemiluminescence immunoassay (ECLIA) intended for use on cobas e immunoassay analyzers. It is used for the determination of cortisol to assist in the recognition and treatment of functional disorders of the adrenal gland. The assay operates on a competition test principle using a monoclonal antibody specifically directed against cortisol.
The system is supplied as part of the Elecsys Cortisol II assay and is intended for in vitro diagnostic use. It is a single-use device and requires specific storage conditions as per manufacturer guidelines. The device has received FDA 510(k) clearance with the product code JFT and is classified under device class 2 for clinical chemistry applications.
Frequently asked questions
What is the Elecsys Cortisol Test System used for?
The Elecsys Cortisol Test System is an electrochemiluminescence immunoassay intended for use on cobas e immunoassay analyzers to determine cortisol levels, assisting in the recognition and treatment of functional disorders of the adrenal gland.
How is the Elecsys Cortisol Test System supplied and is it single-use?
The system is supplied as part of the Elecsys Cortisol II assay and is intended for in vitro diagnostic use. It is a single-use device that requires specific storage conditions as per manufacturer guidelines.
What is the regulatory status of the Elecsys Cortisol Test System?
The Elecsys Cortisol Test System has received FDA 510(k) clearance with the product code JFT and is classified under device class 2 for clinical chemistry applications. It was cleared on September 9, 2002.
What analyzers is the Elecsys Cortisol Test System compatible with?
The Elecsys Cortisol Test System is intended for use on cobas e immunoassay analyzers and operates on a competition test principle using a monoclonal antibody specifically directed against cortisol.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Elecsys® Cortisol II - Roche Diagnostics USA, 06687733500V6.0 Elecsys Cortisol II - elabdoc-prod.roche.com, Elecsys Cortisol II Assay Overview | PDF | Detection Limit - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021218 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K021218 24 fields · synced Sep 23, 2026