FDA product code CFN: Method, Nephelometric, Immunoglobulins (G, A, M)
CFN is the FDA product code for method, nephelometric, 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 61 510(k) submissions under CFN, 2 in the last five years, from 18 different applicants. The average 510(k) review took 146 days (median 71). FDA has posted 20 recalls for CFN devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Method, Nephelometric, 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 CFN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 157 |
| 2019 | 6 | 41 |
| 2023 | 2 | 251 |
Compare with all 510(k) review times · Search every CFN clearance
Top CFN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site Group , Ltd. | 14 | 2019-09-04 |
| The Binding Site, Ltd. | 13 | 2009-12-30 |
| Dade Behring, Inc. | 6 | 2008-07-28 |
| Beckman Coulter, Inc. | 4 | 2017-01-09 |
| Olympus America, Inc. | 3 | 2008-02-11 |
13 more applicants have CFN clearances. See the full list in Caduvo.
Most recent CFN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233663 | Siemens Healthcare Diagnostics Products GmbH | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | 2023-12-13 | 28 |
| K221114 | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Immunoglobulin G (IgG) | 2023-08-02 | 474 |
| K192116 | The Binding Site Group , Ltd. | Human IgA liquid reagent kit for Use on SPAPlus | 2019-09-04 | 29 |
| K191985 | The Binding Site Group , Ltd. | Optilite IgA Kit | 2019-08-19 | 25 |
| K191635 | The Binding Site Group , Ltd. | Optilite IgM Kit | 2019-07-15 | 26 |
Recalls for CFN devices
20 product recalls in 12 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2024-05-27.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CFN?
CFN is the FDA product code for method, nephelometric, 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 CFN?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CFN?
Across 61 cleared submissions the average was 146 days from receipt to decision (median 71).
Which companies have the most CFN clearances?
The Binding Site Group , Ltd. (14); The Binding Site, Ltd. (13); Dade Behring, Inc. (6); Beckman Coulter, Inc. (4); Olympus America, Inc. (3).
Have CFN devices been recalled?
Yes: 20 product recalls across 12 recall events; the most recent began 2024-05-27.
Next steps
- Run an FDA pathway report with predicate devices for product code CFN
- Run a recall and safety report across every CFN manufacturer
- Watch product code CFN 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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