FDA product code CFF: Immunoelectrophoretic, Immunoglobulins, (G, A, M)
CFF is the FDA product code for immunoelectrophoretic, immunoglobulins, (g, a, m). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 29 510(k) submissions under CFF, from 13 different applicants. The average 510(k) review took 141 days (median 109). FDA has posted 4 recalls for CFF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Immunoelectrophoretic, Immunoglobulins, (G, A, M) |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CFF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 174 |
| 2019 | 2 | 59 |
| 2021 | 1 | 381 |
Compare with all 510(k) review times · Search every CFF clearance
Top CFF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sebia | 8 | 2021-11-12 |
| Helena Laboratories | 6 | 2006-07-06 |
| Morax | 3 | 2003-11-04 |
| Kamiya Biomedical Co. | 2 | 1999-11-30 |
| The Binding Site, Ltd. | 2 | 1993-02-23 |
8 more applicants have CFF clearances. See the full list in Caduvo.
Most recent CFF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203184 | Sebia | HYDRASHIFT 2/4 isatuximab | 2021-11-12 | 381 |
| K192095 | Sebia | CAPI 3 Immunotyping, Capillarys 3 Tera | 2019-11-01 | 88 |
| K190851 | Sebia | HYDRASHIFT 2/4 daratumumab | 2019-05-02 | 30 |
| K172195 | Sebia | HYDRASHIFT 2/4 daratumumab, daratumumab Control | 2018-01-11 | 174 |
| K161928 | Sebia | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | 2016-12-21 | 160 |
Recalls for CFF devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-09-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code CFF?
CFF is the FDA product code for immunoelectrophoretic, immunoglobulins, (g, a, m). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is CFF?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CFF?
Across 29 cleared submissions the average was 141 days from receipt to decision (median 109).
Which companies have the most CFF clearances?
Sebia (8); Helena Laboratories (6); Morax (3); Kamiya Biomedical Co. (2); The Binding Site, Ltd. (2).
Have CFF devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-09-28.
Next steps
- Run an FDA pathway report with predicate devices for product code CFF
- Run a recall and safety report across every CFF manufacturer
- Watch product code CFF 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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