Cortisol Enhanced Luminescence Assay Kit
by Amersham Corp. 510(k)
Active
510(k) K880687
Overview
The Cortisol Enhanced Luminescence Assay Kit is a Class II in vitro diagnostic device designed for the quantitative measurement of cortisol levels in biological samples. It operates as a radioimmunoassay, utilizing radiolabeled antigens and specific antibody binding to determine cortisol concentration. The kit is intended for use in clinical chemistry settings to support endocrine function assessment.
This device is supplied as a complete assay kit and is intended for single-use applications in laboratory environments. It is regulated under FDA product code CGR and was cleared via the 510(k) premarket notification pathway under number K880687. The kit must be stored under specified conditions as outlined by the manufacturer and is subject to special controls applicable to Class II radioimmunoassay devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880687 | Date24 Mar 1988 | 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- Withdrawn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 Amersham Corp.
Questions
What is the Cortisol Enhanced Luminescence Assay Kit used for?
It is an in vitro diagnostic device used for the quantitative measurement of cortisol levels in biological samples. It supports endocrine function assessment in clinical chemistry settings by utilizing radiolabeled antigens and specific antibody binding.
How is the kit supplied and intended for use?
The device is supplied as a complete assay kit. It is intended for single-use applications in laboratory environments and is not designed for reuse or multi-patient testing scenarios.
What are the storage requirements for this assay kit?
The kit must be stored under specified conditions as outlined by the manufacturer. These conditions are critical to maintaining the integrity of the radiolabeled components and antibody reagents.
Is this device regulated as a radioimmunoassay?
Yes, it is regulated under FDA product code CGR and is subject to special controls applicable to Class II radioimmunoassay devices. Its regulatory classification reflects its use of radioactive materials in diagnostic testing.