FDA product code DAE: Complement C9, Antigen, Antiserum, Control
DAE is the FDA product code for complement c9, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. FDA has cleared 6 510(k) submissions under DAE, from 5 different applicants. The average 510(k) review took 174 days (median 188).
Classification
| Field | Value |
|---|---|
| Device name | Complement C9, 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 DAE clearance
Top DAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 2015-08-28 |
| The Binding Site, Ltd. | 1 | 1999-09-17 |
| Quidel Corp. | 1 | 1998-07-29 |
| Wako Chemicals USA, Inc. | 1 | 1995-12-18 |
| Incstar Corp. | 1 | 1995-10-13 |
Most recent DAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150412 | The Binding Site Group , Ltd. | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | 2015-08-28 | 191 |
| K113349 | The Binding Site Group , Ltd. | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO | 2012-07-11 | 240 |
| K992488 | The Binding Site, Ltd. | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | 1999-09-17 | 53 |
| K974111 | Quidel Corp. | QUIDEL CH50 EQ EIA | 1998-07-29 | 271 |
| K954145 | Wako Chemicals USA, Inc. | WAKO AUTOKIT CH50 | 1995-12-18 | 104 |
Recalls for DAE devices
openFDA lists no recalls for product code DAE.
Frequently asked questions
What is FDA product code DAE?
DAE is the FDA product code for complement c9, 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 DAE?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
How long does a 510(k) take for product code DAE?
Across 6 cleared submissions the average was 174 days from receipt to decision (median 188).
Which companies have the most DAE clearances?
The Binding Site Group , Ltd. (2); The Binding Site, Ltd. (1); Quidel Corp. (1); Wako Chemicals USA, Inc. (1); Incstar Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DAE
- Run a recall and safety report across every DAE manufacturer
- Watch product code DAE 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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