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U.S. Department of Health and Human Services

Product Classification
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Device assays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors
Definition An in vitro diagnostic device intended to detect and/or measure pre-existing endogenous antibodies to adeno-associated virus (AAV) viral vectors in patients who may receive AAV vector-based gene therapy products.
Physical State Consists of assay plates, reagents, instruments, and software.
Technical Method Enzyme linked immunosorbent assay (ELISA), total antibody assay, cell-based assay. The assay may or may not be specific for immunoglobulin isotypes.
Target Area Plasma, serum, or whole blood.
Review Panel Immunology
Product CodeQWQ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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