CJM · Radioimmunoassay, Aldosterone
Clinical Chemistry · 21 CFR 862.1045 · Class 2
Overview
| Product Code | CJM |
|---|---|
| Device Name | Radioimmunoassay, Aldosterone |
| Regulation | 21 CFR 862.1045 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
Classification Rationale
Class II.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | Apr 21, 2015 | SESE |
| K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | Diasorin | Apr 9, 2013 | SESE |
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Nichols Institute Diagnostics | Jun 1, 2005 | SESE |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Nichols Institute Diagnostics | Jul 31, 2003 | SESE |
| K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | Diagnostic Systems Laboratories, Inc. | Feb 13, 1995 | SESE |
| K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) | Diagnostic Systems Laboratories, Inc. | Jul 10, 1992 | SESE |
| K862204 | RSL (125I) ALDOSTERONE KIT | Radioassay Systems Laboratories, Inc. | Sep 25, 1986 | SESE |
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | Mar 2, 1984 | SESE |
| K831178 | COAT-A-COUNT NO-EXTRACTION ALDOSTERONE | Diagnostic Products Corp. | May 27, 1983 | SESE |
| K800775 | ALDOCTK-125 | Sorin Biomedica, Fiat, USA, Inc. | Apr 21, 1980 | SESE |
| K781504 | 125I-ALDOSTERONE RIA DIAG. KIT | Abbott Laboratories | Nov 22, 1978 | SESE |
| K771526 | 125 I ALDOSTERONE RIA KIT | Diagnostic Products Corp. | Aug 25, 1977 | SESE |
Top Applicants
- Diagnostic Products Corp. — 2 clearances
- Diagnostic Systems Laboratories, Inc. — 2 clearances
- Nichols Institute Diagnostics — 2 clearances
- Abbott Laboratories — 1 clearance
- Diasorin — 1 clearance
