FDA product code DBF: Ferritin, Antigen, Antiserum, Control
DBF is the FDA product code for ferritin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5340 and reviewed by the Immunology panel. FDA has cleared 87 510(k) submissions under DBF, from 62 different applicants. The average 510(k) review took 67 days (median 44). FDA has posted 7 recalls for DBF devices.
Classification
| Field | Value |
|---|---|
| Device name | Ferritin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5340 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2020 | 1 | 267 |
| 2021 | 1 | 624 |
Compare with all 510(k) review times · Search every DBF clearance
Top DBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amersham Corp. | 6 | 1989-10-17 |
| Abbott Laboratories | 3 | 1998-12-07 |
| Diagnostic Products Corp. | 3 | 1987-11-25 |
| Hybritech, Inc. | 3 | 1986-10-08 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2017-08-31 |
57 more applicants have DBF clearances. See the full list in Caduvo.
Most recent DBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193650 | DiaSorin, Inc. | LIAISON Ferritin | 2021-09-14 | 624 |
| K191562 | HORIBA ABX SAS | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | 2020-03-06 | 267 |
| K171642 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Ferritin Assay | 2017-08-31 | 90 |
| K133083 | Diazyme Laboratories | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET | 2014-06-24 | 267 |
| K121232 | Kamiya Biomedical Company | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | 2012-05-24 | 30 |
Recalls for DBF devices
7 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-11-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
Frequently asked questions
What is FDA product code DBF?
DBF is the FDA product code for ferritin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5340 and reviewed by the Immunology panel.
What device class is DBF?
Class II, regulation 21 CFR 866.5340. Typical premarket route: 510(k).
How long does a 510(k) take for product code DBF?
Across 87 cleared submissions the average was 67 days from receipt to decision (median 44).
Which companies have the most DBF clearances?
Amersham Corp. (6); Abbott Laboratories (3); Diagnostic Products Corp. (3); Hybritech, Inc. (3); Siemens Healthcare Diagnostics, Inc. (2).
Have DBF devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2018-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code DBF
- Run a recall and safety report across every DBF manufacturer
- Watch product code DBF 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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