FDA product code DAK: Complement C1q, Antigen, Antiserum, Control
DAK is the FDA product code for complement c1q, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. FDA has cleared 28 510(k) submissions under DAK, from 20 different applicants. The average 510(k) review took 96 days (median 50). FDA has posted 3 recalls for DAK devices.
Classification
| Field | Value |
|---|---|
| Device name | Complement C1q, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5240 |
| 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 DAK clearance
Top DAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho Diagnostic Systems, Inc. | 3 | 1984-06-13 |
| The Binding Site, Ltd. | 2 | 2003-09-10 |
| Cytotech, Inc. | 2 | 1988-08-04 |
| Biostar Medical Products, Inc. | 2 | 1986-06-20 |
| Gamma Medical Products, Inc. | 2 | 1984-06-22 |
15 more applicants have DAK clearances. See the full list in Caduvo.
Most recent DAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031563 | The Binding Site, Ltd. | BINDAZYME CLQ CIC EIA KIT | 2003-09-10 | 114 |
| K032254 | Ibl GmbH | IBL C1Q-CIC CIA TEST | 2003-08-29 | 38 |
| K012576 | American Laboratory Products Co., Ltd. | CIC-C1Q EIA | 2002-01-29 | 173 |
| K973203 | Sangstat Medical Corp. | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES | 1998-09-30 | 400 |
| K972873 | Immunomedics, Inc. | IMMUSTRIP HAMA IGG | 1998-03-17 | 225 |
Recalls for DAK devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-04.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code DAK?
DAK is the FDA product code for complement c1q, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel.
What device class is DAK?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAK?
Across 28 cleared submissions the average was 96 days from receipt to decision (median 50).
Which companies have the most DAK clearances?
Ortho Diagnostic Systems, Inc. (3); The Binding Site, Ltd. (2); Cytotech, Inc. (2); Biostar Medical Products, Inc. (2); Gamma Medical Products, Inc. (2).
Have DAK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2017-04-04.
Next steps
- Run an FDA pathway report with predicate devices for product code DAK
- Run a recall and safety report across every DAK manufacturer
- Watch product code DAK 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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