CIZ · Radioimmunoassay, Androstenedione
Clinical Chemistry · 21 CFR 862.1075 · Class 1
Overview
| Product Code | CIZ |
|---|---|
| Device Name | Radioimmunoassay, Androstenedione |
| Regulation | 21 CFR 862.1075 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.
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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963002 | ACTIVE ANDROSTENEDIONE EIA | Diagnostic Systems Laboratories, Inc. | Aug 16, 1996 | SESE |
| K954755 | COAT-A-COUNT DIRECT ANDROSTENEDIONE | Diagnostic Products Corp. | Nov 29, 1995 | SESE |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | Diagnostic Systems Laboratories, Inc. | Jan 10, 1994 | SESE |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Immuchem Corp. | Mar 14, 1986 | SESE |
| K854673 | DSL ANDROSTENEDIONE RIA (DSL # 4200) | Diagnostic Systems Laboratories, Inc. | Jan 22, 1986 | SESE |
| K854650 | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) | Diagnostic Systems Laboratories, Inc. | Dec 13, 1985 | SESE |
| K844398 | COAT-A-COUNT ANDROSTENEDIONE RIA KIT | Diagnostic Products Corp. | Dec 10, 1984 | SESE |
| K842960 | ANDROSTENEDIONE BY RIA | Radioassay Systems Laboratories, Inc. | Sep 27, 1984 | SESE |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Wien Laboratories, Inc. | Sep 12, 1983 | SESE |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Diagnostics Biochem Canada, Inc. | Oct 31, 1980 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 4 clearances
- Diagnostic Products Corp. — 2 clearances
- Diagnostics Biochem Canada, Inc. — 1 clearance
- Immuchem Corp. — 1 clearance
- Radioassay Systems Laboratories, Inc. — 1 clearance
