FDA product code PDE: Immunoglobulin M Kappa Heavy And Light Chain Combined
PDE is the FDA product code for immunoglobulin m 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 2 510(k) submissions under PDE. The average 510(k) review took 128 days (median 128).
Definition
Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Immunoglobulin M 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 |
Compare with all 510(k) review times · Search every PDE clearance
Top PDE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 2015-12-18 |
Most recent PDE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152389 | The Binding Site Group , Ltd. | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | 2015-12-18 | 116 |
| K140686 | The Binding Site Group , Ltd. | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS | 2014-08-06 | 140 |
Recalls for PDE devices
openFDA lists no recalls for product code PDE.
Frequently asked questions
What is FDA product code PDE?
PDE is the FDA product code for immunoglobulin m 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 PDE?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDE?
Across 2 cleared submissions the average was 128 days from receipt to decision (median 128).
Which companies have the most PDE clearances?
The Binding Site Group , Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PDE
- Run a recall and safety report across every PDE manufacturer
- Watch product code PDE 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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