FDA product code DDC: Thyroglobulin, Antigen, Antiserum, Control
DDC is the FDA product code for thyroglobulin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel. FDA has cleared 13 510(k) submissions under DDC, from 10 different applicants. The average 510(k) review took 64 days (median 45). FDA has posted 1 recall for DDC devices.
Classification
| Field | Value |
|---|---|
| Device name | Thyroglobulin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5870 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DDC clearance
Top DDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 3 | 2000-02-18 |
| Burroughs Wellcome Co. | 2 | 1978-06-14 |
| Quest Intl., Inc. | 1 | 2003-01-06 |
| Beckman Coulter, Inc. | 1 | 2001-09-07 |
| Monobind | 1 | 1997-07-03 |
5 more applicants have DDC clearances. See the full list in Caduvo.
Most recent DDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023592 | Quest Intl., Inc. | SERAQUEST ANTI-THYROGLOBULIN | 2003-01-06 | 73 |
| K012208 | Beckman Coulter, Inc. | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 | 2001-09-07 | 53 |
| K000363 | Zeus Scientific, Inc. | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | 2000-02-18 | 14 |
| K991610 | Zeus Scientific, Inc. | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | 1999-06-25 | 46 |
| K991179 | Zeus Scientific, Inc. | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | 1999-06-17 | 71 |
Recalls for DDC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-10-26.
Frequently asked questions
What is FDA product code DDC?
DDC is the FDA product code for thyroglobulin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel.
What device class is DDC?
Class II, regulation 21 CFR 866.5870. Typical premarket route: 510(k).
How long does a 510(k) take for product code DDC?
Across 13 cleared submissions the average was 64 days from receipt to decision (median 45).
Which companies have the most DDC clearances?
Zeus Scientific, Inc. (3); Burroughs Wellcome Co. (2); Quest Intl., Inc. (1); Beckman Coulter, Inc. (1); Monobind (1).
Have DDC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-10-26.
Next steps
- Run an FDA pathway report with predicate devices for product code DDC
- Run a recall and safety report across every DDC manufacturer
- Watch product code DDC 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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