FDA product code PAF: Voltage Gated Calcium Channel (Vgcc) Antibody Assay
PAF is the FDA product code for voltage gated calcium channel (vgcc) antibody assay. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under PAF. The average 510(k) review took 324 days (median 324).
Definition
Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Voltage Gated Calcium Channel (Vgcc) Antibody Assay |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| 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 PAF clearance
Top PAF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kronus Market Development Associates, Inc. | 1 | 2012-05-30 |
Most recent PAF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111956 | Kronus Market Development Associates, Inc. | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT | 2012-05-30 | 324 |
Recalls for PAF devices
openFDA lists no recalls for product code PAF.
Frequently asked questions
What is FDA product code PAF?
PAF is the FDA product code for voltage gated calcium channel (vgcc) antibody assay. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is PAF?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAF?
Across 1 cleared submissions the average was 324 days from receipt to decision (median 324).
Which companies have the most PAF clearances?
Kronus Market Development Associates, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PAF
- Run a recall and safety report across every PAF manufacturer
- Watch product code PAF 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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