FDA product code CDD: Radioassay, Vitamin B12
CDD is the FDA product code for radioassay, vitamin b12. It is a Class II device, regulated under 21 CFR 862.1810 and reviewed by the Clinical Chemistry panel. FDA has cleared 78 510(k) submissions under CDD, 2 in the last five years, from 45 different applicants. The average 510(k) review took 98 days (median 78); 271 days on average over the last three years. FDA has posted 12 recalls for CDD devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioassay, Vitamin B12 |
| Device class | Class II |
| Regulation | 21 CFR 862.1810 |
| 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 CDD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 105 |
| 2019 | 2 | 148 |
| 2022 | 1 | 59 |
| 2024 | 1 | 271 |
Compare with all 510(k) review times · Search every CDD clearance
Top CDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Axis-Shield Diagnostics, Ltd. | 5 | 2024-07-31 |
| Diagnostic Products Corp. | 5 | 1997-05-16 |
| Beckman Coulter, Inc. | 4 | 2022-12-23 |
| Abbott Laboratories | 4 | 2012-05-17 |
| Ciba Corning Diagnostics Corp. | 4 | 1991-10-25 |
40 more applicants have CDD clearances. See the full list in Caduvo.
Most recent CDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233541 | Axis-Shield Diagnostics, Ltd. | ARCHITECT Active-B12 (Holotranscobalamin) | 2024-07-31 | 271 |
| K223289 | Beckman Coulter, Inc. | Access Vitamin B12 | 2022-12-23 | 59 |
| K190298 | Beckman Coulter Biomedical GmbH | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 | 2019-10-04 | 235 |
| K192064 | DiaSorin, Inc. | LIAISON Vitamin B12 | 2019-10-02 | 62 |
| K172133 | Axis-Shield Diagnostics, Ltd. | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | 2017-10-27 | 105 |
Recalls for CDD devices
12 product recalls in 10 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-02-27.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code CDD?
CDD is the FDA product code for radioassay, vitamin b12. It is a Class II device, regulated under 21 CFR 862.1810 and reviewed by the Clinical Chemistry panel.
What device class is CDD?
Class II, regulation 21 CFR 862.1810. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDD?
Across 78 cleared submissions the average was 98 days from receipt to decision (median 78).
Which companies have the most CDD clearances?
Axis-Shield Diagnostics, Ltd. (5); Diagnostic Products Corp. (5); Beckman Coulter, Inc. (4); Abbott Laboratories (4); Ciba Corning Diagnostics Corp. (4).
Have CDD devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2025-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code CDD
- Run a recall and safety report across every CDD manufacturer
- Watch product code CDD 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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