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U.S. Department of Health and Human Services

Product Classification

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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 CodePAF
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons