FDA product code DCN: System, Test, C-Reactive Protein
DCN is the FDA product code for system, test, c-reactive protein. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel. FDA has cleared 70 510(k) submissions under DCN, 2 in the last five years, from 53 different applicants. The average 510(k) review took 94 days (median 70). FDA has posted 5 recalls for DCN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, C-Reactive Protein |
| Device class | Class II |
| Regulation | 21 CFR 866.5270 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DCN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 260 |
| 2018 | 3 | 221 |
| 2020 | 1 | 203 |
| 2023 | 2 | 212 |
Compare with all 510(k) review times · Search every DCN clearance
Top DCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 4 | 2009-03-18 |
| Good Biotech Corp. | 4 | 2005-06-06 |
| Dade Behring, Inc. | 3 | 2006-09-06 |
| The Binding Site Group , Ltd. | 2 | 2018-10-12 |
| Abbott Laboratories | 2 | 2003-07-02 |
48 more applicants have DCN clearances. See the full list in Caduvo.
Most recent DCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232624 | Siemens Healthcare Diagnostic Products GmbH | CardioPhase® hsCRP | 2023-11-27 | 90 |
| K221119 | Siemens Healthcare Diagnostics, Inc. | RCRP Flex reagent cartridge | 2023-03-17 | 333 |
| K192072 | Roche Diagnostics Operations (Rdo) | Tina-quant C-Reactive Protein IV | 2020-02-21 | 203 |
| K180099 | The Binding Site Group , Ltd. | Optilite High Sensitivity C-Reactive Protein Kit | 2018-10-12 | 269 |
| K172868 | The Binding Site Group , Ltd. | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | 2018-02-28 | 161 |
Recalls for DCN devices
5 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-03-11.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DCN?
DCN is the FDA product code for system, test, c-reactive protein. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel.
What device class is DCN?
Class II, regulation 21 CFR 866.5270. Typical premarket route: 510(k).
How long does a 510(k) take for product code DCN?
Across 70 cleared submissions the average was 94 days from receipt to decision (median 70).
Which companies have the most DCN clearances?
Roche Diagnostics Corp. (4); Good Biotech Corp. (4); Dade Behring, Inc. (3); The Binding Site Group , Ltd. (2); Abbott Laboratories (2).
Have DCN devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code DCN
- Run a recall and safety report across every DCN manufacturer
- Watch product code DCN 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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