Cortisol System by EIA
by American Bioclinical, Inc. 510(k)
Active
510(k) K852939
Overview
The Cortisol System by EIA is a radioimmunoassay device designed to measure cortisol levels in plasma and urine. Cortisol, a steroid hormone produced by the adrenal glands, is assessed for diagnosing and monitoring adrenal gland disorders, including conditions such as Cushing’s syndrome or adrenal insufficiency. This system employs enzyme immunoassay technology to provide quantitative analysis of cortisol concentrations.
This device is supplied as a diagnostic test kit and is intended for single-use in clinical chemistry laboratories. It requires FDA 510(k) clearance (K852939) and falls under product code CGR, classified as a Class II medical device. No information regarding sterility, MRI safety, or reusable components is provided in the specifications. Storage and handling instructions are not detailed beyond standard laboratory protocols for immunoassay systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852939 | Date2 Aug 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CGR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1205
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from American Bioclinical, Inc.
Questions
What types of samples can the Cortisol System by EIA measure, and what is it primarily used for in clinical settings?
The Cortisol System by EIA is designed to measure cortisol levels specifically in plasma and urine samples. Clinically, it is used to diagnose and monitor adrenal gland disorders, such as Cushing’s syndrome or adrenal insufficiency, by providing quantitative analysis of cortisol concentrations via enzyme immunoassay technology.
Is the Cortisol System by EIA intended for single-use or repeated use in a laboratory?
The Cortisol System by EIA is intended for single-use only in clinical chemistry laboratories. It is supplied as a diagnostic test kit, meaning each kit is meant for one-time use per test cycle, adhering to standard immunoassay protocols.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?
The Cortisol System by EIA received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). It is classified as a Class II medical device under product code CGR, falling within the Clinical Chemistry advisory committee (CH).
Are there any specific storage or handling instructions provided for this device beyond standard laboratory protocols?
The provided documentation does not specify unique storage or handling instructions beyond general standard laboratory protocols for immunoassay systems. Users should follow typical guidelines for immunoassay devices to ensure accuracy and reliability of cortisol measurements.