Identifiers
- 510(k) Number
- K893954 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 CEDIA Cortisol Assay is a chemiluminescent enzyme immunoassay designed to measure cortisol levels in plasma and urine. Cortisol, a steroid hormone produced by the adrenal glands, plays a key role in metabolism, immune response, and stress regulation. This assay employs a competitive binding technique to quantify cortisol concentrations, providing quantitative results for clinical evaluation of adrenal function, endocrine disorders, or stress-related conditions.
This device is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a reagent kit, it requires reconstitution and preparation per manufacturer instructions before use. The assay is classified as a Class II device under FDA regulations (product code JFT) and has been cleared via a Traditional 510(k) pathway (K893954). It is not intended for single-use or reusable applications and must be stored according to the provided stability guidelines. No MRI safety information or sterility claims are specified in the regulatory data.
Frequently asked questions
What clinical conditions can the CEDIA Cortisol Assay help evaluate, and how does it work?
The CEDIA Cortisol Assay is designed to measure cortisol levels in plasma and urine, which helps clinicians evaluate adrenal function, endocrine disorders, and stress-related conditions. It uses a chemiluminescent enzyme immunoassay with a competitive binding technique to quantify cortisol concentrations, providing quantitative results for clinical assessment.
Is this assay intended for single-use or reusable applications, and how should it be stored?
The CEDIA Cortisol Assay is supplied as a reagent kit and is not intended for single-use or reusable applications. It must be stored according to the manufacturer’s stability guidelines, which are detailed in the provided instructions. Proper storage ensures accuracy and reliability of the assay results.
What type of laboratory setting is this device intended for, and what regulatory pathway was used for clearance?
This assay is intended for use in clinical chemistry laboratories for in vitro diagnostic testing. It was cleared via the FDA’s Traditional 510(k) pathway (K893954) and is classified as a Class II device under FDA regulations (product code JFT). The clearance was based on a determination of substantial equivalence to a predicate device.
Does this assay require any special preparation before use, and what form is it supplied in?
Yes, the CEDIA Cortisol Assay requires reconstitution and preparation per manufacturer instructions before use. It is supplied as a reagent kit, meaning it includes all necessary components for performing the assay in a laboratory setting.
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: CEDIA (TM) CORTISOL ASSAY (K901296) — FDA 510(k) | Innolitics, K893954 - CEDIA CORTISOL ASSAY | FDA 510(k) | Microgenics Corp., CEDIA CORTISOL ASSAY (K893954) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K893954 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K893954 24 fields · synced Sep 20, 2026