Quest Diagnostics AAVrh74 Antibody ELISA CDx
FDA premarket approval P250002 · decided 2025-07-24
Approval details
- PMA number
- P250002
- Trade name
- Quest Diagnostics AAVrh74 Antibody ELISA CDx
- Generic name
- Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
- Applicant
- Quest Diagnostics Nichols Institute
- Date received
- 2025-01-27
- Decision date
- 2025-07-24
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- QWQ
- Advisory committee
- Hematology
- Expedited review
- No
- Location
- San Juan Capistrano, CA
- Statement
- Quest Diagnostics AAVrh74 Antibody ELISA CDx is an enzyme-linked immunosorbent in vitro diagnostic assay intended for the semi-quantitative detection of antibodies (IgG) to AAVrh74 capsid in human serum. The test reports an antibody titer, and a semi-quantitative interpretation of the test results derived from the antibody titer. Patients with an AAVrh74 antibody titer less than 1:400 are reported as not elevated for AAVrh74 antibody titers and may be eligible for treatment with the gene therapy
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