FDA product code CIB: Radioimmunoassay, Angiotensin I And Renin
CIB is the FDA product code for radioimmunoassay, angiotensin i and renin. It is a Class II device, regulated under 21 CFR 862.1085 and reviewed by the Clinical Chemistry panel. FDA has cleared 16 510(k) submissions under CIB, from 14 different applicants. The average 510(k) review took 126 days (median 66). FDA has posted 4 recalls for CIB devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Angiotensin I And Renin |
| Device class | Class II |
| Regulation | 21 CFR 862.1085 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top CIB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 2 | 2006-07-28 |
| Nichols Institute Diagnostics | 2 | 2001-09-06 |
| Immunodiagnostic Systems , Ltd. | 1 | 2013-12-24 |
| DiaSorin, Inc. | 1 | 2013-01-01 |
| Cis Bio International | 1 | 2007-03-30 |
9 more applicants have CIB clearances. See the full list in Caduvo.
Most recent CIB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123763 | Immunodiagnostic Systems , Ltd. | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | 2013-12-24 | 382 |
| K121944 | DiaSorin, Inc. | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | 2013-01-01 | 182 |
| K062120 | Cis Bio International | CISBIO RENIN RIA TEST | 2007-03-30 | 248 |
| K061758 | Diagnostic Systems Laboratories, Inc. | ACTIVE RENIN IRMA | 2006-07-28 | 36 |
| K011128 | Nichols Institute Diagnostics | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) | 2001-09-06 | 146 |
Recalls for CIB devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-01-20.
Frequently asked questions
What is FDA product code CIB?
CIB is the FDA product code for radioimmunoassay, angiotensin i and renin. It is a Class II device, regulated under 21 CFR 862.1085 and reviewed by the Clinical Chemistry panel.
What device class is CIB?
Class II, regulation 21 CFR 862.1085. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIB?
Across 16 cleared submissions the average was 126 days from receipt to decision (median 66).
Which companies have the most CIB clearances?
Diagnostic Systems Laboratories, Inc. (2); Nichols Institute Diagnostics (2); Immunodiagnostic Systems , Ltd. (1); DiaSorin, Inc. (1); Cis Bio International (1).
Have CIB devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2012-01-20.
Next steps
- Run an FDA pathway report with predicate devices for product code CIB
- Run a recall and safety report across every CIB manufacturer
- Watch product code CIB 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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