17-HYDROXY TEST
Device Facts
| Record ID | K772426 |
|---|---|
| Device Name | 17-HYDROXY TEST |
| Applicant | Hycel, Inc. |
| Product Code | CDB · Clinical Chemistry |
| Decision Date | Jan 30, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1385 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders.
