Voltage Gated Calcium Channel (Vgcc) Antibody Assay
The Voltage Gated Calcium Channel (VGCC) Antibody Assay is an immunology in vitro diagnostic device intended for the semi-quantitative determination of VGCC antibodies in human serum; VGCC antibodies may be present in patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS), and results are to be used in conjunction with other clinical, electrodiagnostic, and laboratory findings. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is PAF, with regulation number 866.5660 under the Immunology medical specialty.
Research product code PAF in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PAF
- Device Class
- FDA class 2
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT | May 30, 2012 | Substantially Equivalent | Kronus Market Development Associates, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.