FDA product code DFC: Lipoprotein, Low-Density, Antigen, Antiserum, Control
DFC is the FDA product code for lipoprotein, low-density, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5600 and reviewed by the Immunology panel. FDA has cleared 43 510(k) submissions under DFC, 3 in the last five years, from 28 different applicants. The average 510(k) review took 107 days (median 60); 267 days on average over the last three years. FDA has posted 6 recalls for DFC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lipoprotein, Low-Density, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5600 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DFC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 71 |
| 2022 | 1 | 622 |
| 2025 | 1 | 268 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every DFC clearance
Top DFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wako Chemicals USA, Inc. | 9 | 2000-07-24 |
| Roche Diagnostics Corp. | 3 | 2001-11-16 |
| DiaSorin, Inc. | 3 | 2000-04-25 |
| Diazyme Laboratories, Inc. | 2 | 2026-06-16 |
| Kamiya Biomedical Co. | 2 | 2002-12-13 |
23 more applicants have DFC clearances. See the full list in Caduvo.
Most recent DFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253069 | Diazyme Laboratories, Inc. | Lipoprotein (a) Molarity Assay | 2026-06-16 | 266 |
| K241220 | Roche Diagnostics Operations | Tina-quant Lipoprotein(a) Gen.2 Molarity | 2025-01-24 | 268 |
| K211058 | SENTINEL CH. SpA | Lp(a) Ultra | 2022-12-22 | 622 |
| K180074 | Diazyme Laboratories, Inc. | Diazyme Lipoprotein (a) Assay | 2018-03-22 | 71 |
| K123046 | Siemens Healthcare Diagnostics, Inc. | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | 2012-12-20 | 83 |
Recalls for DFC devices
6 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-12-20.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code DFC?
DFC is the FDA product code for lipoprotein, low-density, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5600 and reviewed by the Immunology panel.
What device class is DFC?
Class II, regulation 21 CFR 866.5600. Typical premarket route: 510(k).
How long does a 510(k) take for product code DFC?
Across 43 cleared submissions the average was 107 days from receipt to decision (median 60).
Which companies have the most DFC clearances?
Wako Chemicals USA, Inc. (9); Roche Diagnostics Corp. (3); DiaSorin, Inc. (3); Diazyme Laboratories, Inc. (2); Kamiya Biomedical Co. (2).
Have DFC devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2024-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code DFC
- Run a recall and safety report across every DFC manufacturer
- Watch product code DFC 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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