FDA product code DBA: Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
DBA is the FDA product code for complement c1 inhibitor (inactivator), antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5250 and reviewed by the Immunology panel. FDA has cleared 13 510(k) submissions under DBA, from 12 different applicants. The average 510(k) review took 90 days (median 59). FDA has posted 1 recall for DBA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5250 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top DBA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 2014-07-18 |
| Dade Behring, Inc. | 1 | 2007-12-21 |
| Kamiya Biomedical Co. | 1 | 2001-07-25 |
| Baxter Healthcare Corp | 1 | 2001-03-19 |
| Crestat Diagnostics, Inc. | 1 | 1997-07-14 |
7 more applicants have DBA clearances. See the full list in Caduvo.
Most recent DBA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141100 | The Binding Site Group , Ltd. | OPTILITE C1 INACTIVATOR KIT | 2014-07-18 | 80 |
| K122304 | The Binding Site Group , Ltd. | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS | 2013-04-15 | 257 |
| K072965 | Dade Behring, Inc. | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | 2007-12-21 | 60 |
| K011780 | Kamiya Biomedical Co. | K-ASSAY C1-INA | 2001-07-25 | 48 |
| K003747 | Baxter Healthcare Corp | C1-INHIBITOR MICROTITER ASSAY DEVICE | 2001-03-19 | 105 |
Recalls for DBA devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-02-01.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code DBA?
DBA is the FDA product code for complement c1 inhibitor (inactivator), antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5250 and reviewed by the Immunology panel.
What device class is DBA?
Class II, regulation 21 CFR 866.5250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DBA?
Across 13 cleared submissions the average was 90 days from receipt to decision (median 59).
Which companies have the most DBA clearances?
The Binding Site Group , Ltd. (2); Dade Behring, Inc. (1); Kamiya Biomedical Co. (1); Baxter Healthcare Corp (1); Crestat Diagnostics, Inc. (1).
Have DBA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-02-01.
Next steps
- Run an FDA pathway report with predicate devices for product code DBA
- Run a recall and safety report across every DBA manufacturer
- Watch product code DBA 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.