FDA product code DDR: Myoglobin, Antigen, Antiserum, Control
DDR is the FDA product code for myoglobin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5680 and reviewed by the Immunology panel. FDA has cleared 46 510(k) submissions under DDR, 1 in the last five years, from 34 different applicants. The average 510(k) review took 76 days (median 55). FDA has posted 12 recalls for DDR devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Myoglobin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5680 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DDR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 88 |
Compare with all 510(k) review times · Search every DDR clearance
Top DDR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 4 | 2023-09-18 |
| Diagnostic Products Corp. | 3 | 1999-06-09 |
| Dade Behring, Inc. | 3 | 1998-12-14 |
| Behring Diagnostics, Inc. | 3 | 1990-12-13 |
| Boehringer Mannheim Corp. | 2 | 1998-09-24 |
29 more applicants have DDR clearances. See the full list in Caduvo.
Most recent DDR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231832 | Beckman Coulter, Inc. | Access Myoglobin | 2023-09-18 | 88 |
| K123785 | Diazyme Laboratories | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | 2013-06-07 | 179 |
| K122599 | Siemens Healthcare Diagnostics, Inc. | ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR | 2012-10-03 | 37 |
| K083260 | Roche Diagnostics | ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN | 2009-10-16 | 345 |
| K080481 | Beckman Coulter, Inc. | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS | 2009-02-20 | 364 |
Recalls for DDR devices
12 product recalls in 10 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-21.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code DDR?
DDR is the FDA product code for myoglobin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5680 and reviewed by the Immunology panel.
What device class is DDR?
Class II, regulation 21 CFR 866.5680. Typical premarket route: 510(k).
How long does a 510(k) take for product code DDR?
Across 46 cleared submissions the average was 76 days from receipt to decision (median 55).
Which companies have the most DDR clearances?
Beckman Coulter, Inc. (4); Diagnostic Products Corp. (3); Dade Behring, Inc. (3); Behring Diagnostics, Inc. (3); Boehringer Mannheim Corp. (2).
Have DDR devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2024-02-21.
Next steps
- Run an FDA pathway report with predicate devices for product code DDR
- Run a recall and safety report across every DDR manufacturer
- Watch product code DDR 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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