CDB · Porter Silber Hydrazone, 17-Hydroxycorticosteroids
Clinical Chemistry · 21 CFR 862.1385 · Class 1
Overview
| Product Code | CDB |
|---|---|
| Device Name | Porter Silber Hydrazone, 17-Hydroxycorticosteroids |
| Regulation | 21 CFR 862.1385 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K772426 | 17-HYDROXY TEST | Hycel, Inc. | Jan 30, 1978 | SESE |
| K761271 | URIN. L7-OH CORTICOSTEROID T(NON HYDRO) | Eppendorf-Brinkmann, Inc. | Feb 14, 1977 | SESE |
Top Applicants
- Eppendorf-Brinkmann, Inc. — 1 clearance
- Hycel, Inc. — 1 clearance
