Radioimmunoassay, Compound S (11-Deoxycortisol)
This device is a radioimmunoassay system used in clinical chemistry to measure Compound S (11-deoxycortisol) in patient specimens, supporting evaluation of the hypothalamic-pituitary-adrenal axis and diagnosis of adrenal insufficiency or Cushing syndrome, particularly in the metyrapone stimulation test. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is JKB, regulated under 21 CFR 862.1185, and assigned to the Clinical Chemistry medical specialty.
Research product code JKB in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JKB
- Device Class
- FDA class 1
- Regulation Number
- 862.1185
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER | Sep 27, 1979 | Substantially Equivalent | Radioassay Systems Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.