FDA product code DCF: Albumin, Antigen, Antiserum, Control
DCF is the FDA product code for albumin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5040 and reviewed by the Immunology panel. FDA has cleared 37 510(k) submissions under DCF, from 27 different applicants. The average 510(k) review took 107 days (median 66). FDA has posted 3 recalls for DCF devices.
Classification
| Field | Value |
|---|---|
| Device name | Albumin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5040 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DCF clearance
Top DCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kallestad Diag, A Div. of Erbamont, Inc. | 4 | 1989-11-06 |
| The Binding Site Group , Ltd. | 3 | 2016-08-25 |
| Dade Behring, Inc. | 2 | 2006-09-19 |
| Behring Diagnostics, Inc. | 2 | 1997-10-20 |
| Beckman Instruments, Inc. | 2 | 1997-04-29 |
22 more applicants have DCF clearances. See the full list in Caduvo.
Most recent DCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153560 | The Binding Site Group , Ltd. | Optilite Low Level Albumin Kit | 2016-08-25 | 255 |
| K143118 | The Binding Site Group , Ltd. | Human Microalbumin kit for use on SPAPLUS | 2015-05-26 | 208 |
| K142346 | Beckman Coulter Ireland, Inc. | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | 2014-10-15 | 54 |
| K121045 | The Binding Site Group , Ltd. | HUMAN ALBUMIN CSF KIT | 2013-06-19 | 439 |
| K113072 | Roche Diagnostics Operations | TINA-QUANT ALBUMIN GEN.2 | 2012-05-14 | 210 |
Recalls for DCF devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-10-14.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code DCF?
DCF is the FDA product code for albumin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5040 and reviewed by the Immunology panel.
What device class is DCF?
Class II, regulation 21 CFR 866.5040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DCF?
Across 37 cleared submissions the average was 107 days from receipt to decision (median 66).
Which companies have the most DCF clearances?
Kallestad Diag, A Div. of Erbamont, Inc. (4); The Binding Site Group , Ltd. (3); Dade Behring, Inc. (2); Behring Diagnostics, Inc. (2); Beckman Instruments, Inc. (2).
Have DCF devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2019-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DCF
- Run a recall and safety report across every DCF manufacturer
- Watch product code DCF 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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