FDA product code DEB: Alpha-2-Macroglobulin, Antigen, Antiserum, Control
DEB is the FDA product code for alpha-2-macroglobulin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5620 and reviewed by the Immunology panel. FDA has cleared 13 510(k) submissions under DEB, from 11 different applicants. The average 510(k) review took 66 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Alpha-2-Macroglobulin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5620 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DEB clearance
Top DEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 2 | 2008-07-21 |
| Beckman Instruments, Inc. | 2 | 1998-02-17 |
| The Binding Site Group , Ltd. | 1 | 2014-04-16 |
| The Binding Site, Ltd. | 1 | 1991-12-20 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 1 | 1989-12-01 |
6 more applicants have DEB clearances. See the full list in Caduvo.
Most recent DEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140664 | The Binding Site Group , Ltd. | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | 2014-04-16 | 29 |
| K081249 | Dade Behring, Inc. | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | 2008-07-21 | 80 |
| K053073 | Dade Behring, Inc. | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | 2006-03-28 | 147 |
| K974564 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | 1998-02-17 | 74 |
| K914389 | The Binding Site, Ltd. | ALPHA-2 MACROGLOBULIN TEST RID KIT | 1991-12-20 | 80 |
Recalls for DEB devices
openFDA lists no recalls for product code DEB.
Frequently asked questions
What is FDA product code DEB?
DEB is the FDA product code for alpha-2-macroglobulin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5620 and reviewed by the Immunology panel.
What device class is DEB?
Class II, regulation 21 CFR 866.5620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DEB?
Across 13 cleared submissions the average was 66 days from receipt to decision (median 31).
Which companies have the most DEB clearances?
Dade Behring, Inc. (2); Beckman Instruments, Inc. (2); The Binding Site Group , Ltd. (1); The Binding Site, Ltd. (1); Kallestad Diag, A Div. of Erbamont, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DEB
- Run a recall and safety report across every DEB manufacturer
- Watch product code DEB 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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