FDA product code PCN: Immunoglobulin G Kappa Heavy And Light Chain Combined
PCN is the FDA product code for immunoglobulin g kappa heavy and light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under PCN, from 2 different applicants. The average 510(k) review took 129 days (median 128).
Definition
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Classification
| Field | Value |
|---|---|
| Device name | Immunoglobulin G Kappa Heavy And Light Chain Combined |
| 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 PCN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 168 |
Compare with all 510(k) review times · Search every PCN clearance
Top PCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 2018-02-15 |
| The Binding Site | 1 | 2013-12-20 |
Most recent PCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172613 | The Binding Site Group , Ltd. | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | 2018-02-15 | 168 |
| K161854 | The Binding Site Group , Ltd. | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | 2016-10-04 | 90 |
| K132555 | The Binding Site | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | 2013-12-20 | 128 |
Recalls for PCN devices
openFDA lists no recalls for product code PCN.
Frequently asked questions
What is FDA product code PCN?
PCN is the FDA product code for immunoglobulin g kappa heavy and light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is PCN?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCN?
Across 3 cleared submissions the average was 129 days from receipt to decision (median 128).
Which companies have the most PCN clearances?
The Binding Site Group , Ltd. (2); The Binding Site (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCN
- Run a recall and safety report across every PCN manufacturer
- Watch product code PCN 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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