FDA product code CJM: Radioimmunoassay, Aldosterone
CJM is the FDA product code for radioimmunoassay, aldosterone. It is a Class II device, regulated under 21 CFR 862.1045 and reviewed by the Clinical Chemistry panel. FDA has cleared 12 510(k) submissions under CJM, from 9 different applicants. The average 510(k) review took 84 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Aldosterone |
| Device class | Class II |
| Regulation | 21 CFR 862.1045 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CJM clearance
Top CJM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nichols Institute Diagnostics | 2 | 2005-06-01 |
| Diagnostic Systems Laboratories, Inc. | 2 | 1995-02-13 |
| Diagnostic Products Corp. | 2 | 1983-05-27 |
| Immunodiagnostic Systems , Ltd. | 1 | 2015-04-21 |
| Diasorin | 1 | 2013-04-09 |
4 more applicants have CJM clearances. See the full list in Caduvo.
Most recent CJM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142994 | Immunodiagnostic Systems , Ltd. | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | 2015-04-21 | 187 |
| K130321 | Diasorin | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | 2013-04-09 | 60 |
| K050784 | Nichols Institute Diagnostics | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | 2005-06-01 | 65 |
| K032188 | Nichols Institute Diagnostics | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | 2003-07-31 | 14 |
| K943397 | Diagnostic Systems Laboratories, Inc. | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | 1995-02-13 | 214 |
Recalls for CJM devices
openFDA lists no recalls for product code CJM.
Frequently asked questions
What is FDA product code CJM?
CJM is the FDA product code for radioimmunoassay, aldosterone. It is a Class II device, regulated under 21 CFR 862.1045 and reviewed by the Clinical Chemistry panel.
What device class is CJM?
Class II, regulation 21 CFR 862.1045. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJM?
Across 12 cleared submissions the average was 84 days from receipt to decision (median 72).
Which companies have the most CJM clearances?
Nichols Institute Diagnostics (2); Diagnostic Systems Laboratories, Inc. (2); Diagnostic Products Corp. (2); Immunodiagnostic Systems , Ltd. (1); Diasorin (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJM
- Run a recall and safety report across every CJM manufacturer
- Watch product code CJM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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