Code of Federal Regulations Title 21. Food and Drugs § 21.862.1385 17–Hydroxycorticosteroids (17–ketogenic steroids) test system

(a) 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.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.