21 CFR 862.1385 — Zimmerman/Norymberski, 17-Ketogenic Steroids
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1385
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CCZ | Zimmerman/Norymberski, 17-Ketogenic Steroids | 1 | 1 | |
| CDB | Porter Silber Hydrazone, 17-Hydroxycorticosteroids | 1 | 2 | |
| CDG | Chromatography Separation/Zimmerman 17-Ketogenic Steroids | 1 | 1 | |
| JHD | Fluorometric Method, 17-Hydroxycorticosteroids | 1 | 0 | |
| JHE | Radioassay, 17-Hydroxycorticosteroids | 1 | 0 |
