FDA product code CGN: Acid, Folic, Radioimmunoassay
CGN is the FDA product code for acid, folic, radioimmunoassay. It is a Class II device, regulated under 21 CFR 862.1295 and reviewed by the Clinical Chemistry panel. FDA has cleared 64 510(k) submissions under CGN, 2 in the last five years, from 34 different applicants. The average 510(k) review took 85 days (median 64); 266 days on average over the last three years. FDA has posted 28 recalls for CGN devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Folic, Radioimmunoassay |
| Device class | Class II |
| Regulation | 21 CFR 862.1295 |
| 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 CGN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 265 |
| 2020 | 1 | 230 |
| 2023 | 1 | 265 |
| 2024 | 1 | 266 |
Compare with all 510(k) review times · Search every CGN clearance
Top CGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 5 | 2023-08-23 |
| Abbott Laboratories | 5 | 2010-03-05 |
| Bio-Rad | 5 | 1995-02-03 |
| Roche Diagnostics Corp. | 4 | 2009-06-19 |
| Diagnostic Products Corp. | 4 | 1999-11-12 |
29 more applicants have CGN clearances. See the full list in Caduvo.
Most recent CGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233060 | Roche Diagnostics | Elecsys Folate III | 2024-06-17 | 266 |
| K223590 | Beckman Coulter, Inc. | Access Folate Assay | 2023-08-23 | 265 |
| K192586 | DiaSorin, Inc. | LIAISON® Folate | 2020-05-06 | 230 |
| K172201 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Folate Assay | 2018-04-12 | 265 |
| K161646 | Diazyme Laboratories | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | 2016-11-04 | 142 |
Recalls for CGN devices
28 product recalls in 20 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2024-07-03.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2019 | 3 |
| 2023 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CGN?
CGN is the FDA product code for acid, folic, radioimmunoassay. It is a Class II device, regulated under 21 CFR 862.1295 and reviewed by the Clinical Chemistry panel.
What device class is CGN?
Class II, regulation 21 CFR 862.1295. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGN?
Across 64 cleared submissions the average was 85 days from receipt to decision (median 64).
Which companies have the most CGN clearances?
Beckman Coulter, Inc. (5); Abbott Laboratories (5); Bio-Rad (5); Roche Diagnostics Corp. (4); Diagnostic Products Corp. (4).
Have CGN devices been recalled?
Yes: 28 product recalls across 20 recall events; the most recent began 2024-07-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CGN
- Run a recall and safety report across every CGN manufacturer
- Watch product code CGN 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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