FDA product code DDG: Transferrin, Antigen, Antiserum, Control
DDG is the FDA product code for transferrin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel. FDA has cleared 48 510(k) submissions under DDG, 1 in the last five years, from 34 different applicants. The average 510(k) review took 97 days (median 68); 84 days on average over the last three years. FDA has posted 6 recalls for DDG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Transferrin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5880 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DDG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 94 |
| 2020 | 1 | 382 |
| 2024 | 1 | 84 |
Compare with all 510(k) review times · Search every DDG clearance
Top DDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 5 | 2007-03-21 |
| Beckman Instruments, Inc. | 4 | 1997-08-20 |
| Roche Diagnostics Corp. | 3 | 2001-09-19 |
| Boehringer Mannheim Corp. | 3 | 1993-11-03 |
| Beckman Coulter, Inc. | 2 | 2024-07-03 |
29 more applicants have DDG clearances. See the full list in Caduvo.
Most recent DDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240987 | Beckman Coulter, Inc. | Access sTfR | 2024-07-03 | 84 |
| K190495 | Biosystems S.A. | Transferrin | 2020-03-16 | 382 |
| K182095 | Roche Diagnostics Operations (Rdo) | Tina-quant Transferrin ver.2 (urine application) | 2018-11-05 | 94 |
| K120236 | The Binding Site Group , Ltd. | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | 2013-02-13 | 384 |
| K080634 | Beckman Coulter, Inc. | ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 | 2008-08-11 | 158 |
Recalls for DDG devices
6 product recalls in 4 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2022-06-09.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code DDG?
DDG is the FDA product code for transferrin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel.
What device class is DDG?
Class II, regulation 21 CFR 866.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code DDG?
Across 48 cleared submissions the average was 97 days from receipt to decision (median 68).
Which companies have the most DDG clearances?
Dade Behring, Inc. (5); Beckman Instruments, Inc. (4); Roche Diagnostics Corp. (3); Boehringer Mannheim Corp. (3); Beckman Coulter, Inc. (2).
Have DDG devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2022-06-09.
Next steps
- Run an FDA pathway report with predicate devices for product code DDG
- Run a recall and safety report across every DDG manufacturer
- Watch product code DDG 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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