PAF

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Product code

PAF

Device name

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Device class

Class 2

21 CFR

21 CFR 866.5660

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).