FDA product code DEM: Alpha-1-Antitrypsin, Antigen, Antiserum, Control
DEM is the FDA product code for alpha-1-antitrypsin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel. FDA has cleared 30 510(k) submissions under DEM, from 23 different applicants. The average 510(k) review took 93 days (median 73). FDA has posted 1 recall for DEM devices.
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-Antitrypsin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5130 |
| 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 DEM clearance
Top DEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 5 | 1997-10-03 |
| Dade Behring, Inc. | 2 | 2007-01-11 |
| The Binding Site, Ltd. | 2 | 2001-07-30 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 | 1988-02-10 |
| The Binding Site Group , Ltd. | 1 | 2013-07-03 |
18 more applicants have DEM clearances. See the full list in Caduvo.
Most recent DEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123256 | The Binding Site Group , Ltd. | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | 2013-07-03 | 258 |
| K063610 | Dade Behring, Inc. | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | 2007-01-11 | 38 |
| K053072 | Dade Behring, Inc. | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | 2006-03-28 | 147 |
| K052819 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III | 2005-12-23 | 80 |
| K050596 | Biokit, S.A. | QUANTIA A1-AT | 2005-05-13 | 66 |
Recalls for DEM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code DEM?
DEM is the FDA product code for alpha-1-antitrypsin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel.
What device class is DEM?
Class II, regulation 21 CFR 866.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code DEM?
Across 30 cleared submissions the average was 93 days from receipt to decision (median 73).
Which companies have the most DEM clearances?
Ventana Medical Systems, Inc. (5); Dade Behring, Inc. (2); The Binding Site, Ltd. (2); Kallestad Diag, A Div. of Erbamont, Inc. (2); The Binding Site Group , Ltd. (1).
Have DEM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-08-23.
Next steps
- Run an FDA pathway report with predicate devices for product code DEM
- Run a recall and safety report across every DEM manufacturer
- Watch product code DEM 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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