FDA product code DFH: Kappa, Antigen, Antiserum, Control
DFH is the FDA product code for kappa, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. FDA has cleared 63 510(k) submissions under DFH, 8 in the last five years, from 23 different applicants. The average 510(k) review took 148 days (median 75); 175 days on average over the last three years. FDA has posted 2 recalls for DFH devices.
Classification
| Field | Value |
|---|---|
| Device name | Kappa, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DFH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 158 |
| 2018 | 3 | 125 |
| 2019 | 1 | 29 |
| 2021 | 2 | 566 |
| 2022 | 4 | 380 |
| 2024 | 2 | 266 |
| 2025 | 2 | 84 |
Compare with all 510(k) review times · Search every DFH clearance
Top DFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amico Lab, Inc. | 14 | 1982-11-17 |
| The Binding Site, Ltd. | 8 | 2024-01-24 |
| Siemens Healthcare Diagnostics Products GmbH | 6 | 2022-03-02 |
| Diazyme Laboratories, Inc. | 4 | 2025-12-19 |
| The Binding Site Group , Ltd. | 4 | 2025-05-23 |
18 more applicants have DFH clearances. See the full list in Caduvo.
Most recent DFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253358 | Diazyme Laboratories, Inc. | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | 2025-12-19 | 80 |
| K250549 | The Binding Site Group , Ltd. | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | 2025-05-23 | 87 |
| K231601 | Sebia | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | 2024-02-23 | 267 |
| K231290 | The Binding Site, Ltd. | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | 2024-01-24 | 265 |
| K210623 | Sebia | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | 2022-11-18 | 626 |
Recalls for DFH devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-05-20.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code DFH?
DFH is the FDA product code for kappa, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel.
What device class is DFH?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFH?
Across 63 cleared submissions the average was 148 days from receipt to decision (median 75).
Which companies have the most DFH clearances?
Amico Lab, Inc. (14); The Binding Site, Ltd. (8); Siemens Healthcare Diagnostics Products GmbH (6); Diazyme Laboratories, Inc. (4); The Binding Site Group , Ltd. (4).
Have DFH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2021-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code DFH
- Run a recall and safety report across every DFH manufacturer
- Watch product code DFH 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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