FDA product code DER: Alpha-1-Lipoprotein, Antigen, Antiserum, Control
DER is the FDA product code for alpha-1-lipoprotein, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5580 and reviewed by the Immunology panel. FDA has cleared 17 510(k) submissions under DER, from 11 different applicants. The average 510(k) review took 93 days (median 51). FDA has posted 2 recalls for DER devices.
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-Lipoprotein, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5580 |
| 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 DER clearance
Top DER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crestat Diagnostics, Inc. | 3 | 1997-08-01 |
| Photec Diagnostics, Inc. | 3 | 1986-01-24 |
| Roche Diagnostics Corp. | 2 | 2001-11-16 |
| Kamiya Biomedical Co. | 2 | 1999-10-28 |
| Bayer Corp. | 1 | 2000-05-18 |
6 more applicants have DER clearances. See the full list in Caduvo.
Most recent DER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013249 | Roche Diagnostics Corp. | TINA-QUANT APOLIPOPROTEIN VER.2 | 2001-11-16 | 49 |
| K000921 | Bayer Corp. | BAYER ADVIA IMS SYSTEM; 200 + 3 | 2000-05-18 | 57 |
| K993354 | Kamiya Biomedical Co. | K-ASSAY APO B | 1999-10-28 | 23 |
| K993345 | Kamiya Biomedical Co. | K-ASSAY APO AI | 1999-10-25 | 20 |
| K990594 | Roche Diagnostics Corp. | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | 1999-04-14 | 49 |
Recalls for DER devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code DER?
DER is the FDA product code for alpha-1-lipoprotein, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5580 and reviewed by the Immunology panel.
What device class is DER?
Class II, regulation 21 CFR 866.5580. Typical premarket route: 510(k).
How long does a 510(k) take for product code DER?
Across 17 cleared submissions the average was 93 days from receipt to decision (median 51).
Which companies have the most DER clearances?
Crestat Diagnostics, Inc. (3); Photec Diagnostics, Inc. (3); Roche Diagnostics Corp. (2); Kamiya Biomedical Co. (2); Bayer Corp. (1).
Have DER devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code DER
- Run a recall and safety report across every DER manufacturer
- Watch product code DER 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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