FDA product code CGR: Radioimmunoassay, Cortisol
CGR is the FDA product code for radioimmunoassay, cortisol. It is a Class II device, regulated under 21 CFR 862.1205 and reviewed by the Clinical Chemistry panel. FDA has cleared 84 510(k) submissions under CGR, 2 in the last five years, from 57 different applicants. The average 510(k) review took 64 days (median 42); 223 days on average over the last three years. FDA has posted 7 recalls for CGR devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Cortisol |
| Device class | Class II |
| Regulation | 21 CFR 862.1205 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CGR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 3 | 147 |
| 2023 | 1 | 132 |
| 2025 | 1 | 223 |
Compare with all 510(k) review times · Search every CGR clearance
Top CGR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 5 | 1993-05-11 |
| Beckman Coulter, Inc. | 3 | 2025-03-05 |
| Nichols Institute Diagnostics | 3 | 2004-12-09 |
| Diagnostic Systems Laboratories, Inc. | 3 | 1989-02-23 |
| Corning Medical & Scientific | 3 | 1984-09-04 |
52 more applicants have CGR clearances. See the full list in Caduvo.
Most recent CGR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242190 | Beckman Coulter, Inc. | Access Cortisol; DxC 500i Clinical Analyzer | 2025-03-05 | 223 |
| K223038 | Beckman Coulter, Inc. | Access Cortisol | 2023-02-08 | 132 |
| K202136 | Immunodiagnostic Systems , Ltd. | IDS Cortisol | 2021-04-13 | 256 |
| K202826 | Siemens Healthcare Diagnostics Products, Ltd. | IMMULITE® 2000 Cortisol | 2021-01-15 | 113 |
| K203270 | Siemens Healthcare Diagnostics Products, Ltd. | IMMULITE/IMMULITE® 1000 Cortisol | 2021-01-15 | 71 |
Recalls for CGR devices
7 product recalls in 7 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-09-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code CGR?
CGR is the FDA product code for radioimmunoassay, cortisol. It is a Class II device, regulated under 21 CFR 862.1205 and reviewed by the Clinical Chemistry panel.
What device class is CGR?
Class II, regulation 21 CFR 862.1205. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGR?
Across 84 cleared submissions the average was 64 days from receipt to decision (median 42).
Which companies have the most CGR clearances?
Diagnostic Products Corp. (5); Beckman Coulter, Inc. (3); Nichols Institute Diagnostics (3); Diagnostic Systems Laboratories, Inc. (3); Corning Medical & Scientific (3).
Have CGR devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2025-09-19.
Next steps
- Run an FDA pathway report with predicate devices for product code CGR
- Run a recall and safety report across every CGR manufacturer
- Watch product code CGR 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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