Radioimmunoassay, Aldosterone
The Radioimmunoassay, Aldosterone test system (product code CJM) is an in-vitro diagnostic device used in clinical chemistry to measure aldosterone, the primary mineralocorticoid hormone, in plasma or urine using a radioimmunoassay technique without prior chromatographic separation. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1045 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
Basic Information
- Product Code
- CJM
- Device Class
- FDA class 2
- Regulation Number
- 862.1045
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | Apr 21, 2015 | Substantially Equivalent | Immunodiagnostic Systems , Ltd. |
| K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | Apr 09, 2013 | Substantially Equivalent | Diasorin |
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Jun 01, 2005 | Substantially Equivalent | Nichols Institute Diagnostics |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Jul 31, 2003 | Substantially Equivalent | Nichols Institute Diagnostics |
| K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | Feb 13, 1995 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) | Jul 10, 1992 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K862204 | RSL (125I) ALDOSTERONE KIT | Sep 25, 1986 | Substantially Equivalent | Radioassay Systems Laboratories, Inc. |
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Mar 02, 1984 | Substantially Equivalent | Serono Laboratories, Inc. |
| K831178 | COAT-A-COUNT NO-EXTRACTION ALDOSTERONE | May 27, 1983 | Substantially Equivalent | Diagnostic Products Corp. |
| K800775 | ALDOCTK-125 | Apr 21, 1980 | Substantially Equivalent | Sorin Biomedica, Fiat, USA, Inc. |
| K781504 | 125I-ALDOSTERONE RIA DIAG. KIT | Nov 22, 1978 | Substantially Equivalent | Abbott Laboratories |
| K771526 | 125 I ALDOSTERONE RIA KIT | Aug 25, 1977 | Substantially Equivalent | Diagnostic Products Corp. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.