| Device |
voltage gated calcium channel (vgcc) antibody assay |
| Regulation Description |
Multiple autoantibodies immunological test system. |
| 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. |
| Physical State |
VGCC labeled with 125 Iodine-w-Conotoxin MVIIC (lyophilized) in 12x75 polysterene test tubes; Positive and negative controls; Total Binding & Non-Specific binding tubes; Anti-human IgG; Buffer; Wash solution |
| Technical Method |
Radioimmunoassay (RIA) Assay using radioactive labeled material |
| Target Area |
Serum samples |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Immunology |
|---|
| Product Code | PAF |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.5660
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
