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 Code | QWQ |
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 |