Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
Basic Information
- Device Name
- Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
- Trade Name
- AAV5 DetectCDx
- PMA Number
- P190033
- Device Class
- FDA Class 3
- Product Code
- QWQ
- Generic Name
- Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
- Medical Specialty
- Unknown
- Advisory Committee
- Hematology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 29, 2023
- Date Received
- December 23, 2019
- Expedited Review
- N
- Docket Number
- 23M-3055
Advisory Committee Statement
Approval of the AAV5 DetectCDx by ARUP Laboratories. This device is indicated for:The AAV5 Total Antibody Assay for ROCTAVIAN (valoctocogene roxaparvovec-rvox) Eligibility in Hemophilia A (AAV5 TAb Assay), or AAV5 DetectCDx, is a qualitative in vitro diagnostic test by electrochemiluminescence intended for detection of antibodies in human plasma collected in 3.2% sodium citrate that bind to the adeno-associated virus serotype 5 (AAV5). The AAV5 TAb Assay is indicated as an aid in the selection of adult hemophilia A patients for whom ROCTAVIAN treatment is being considered. Patients that are anti-AAV5 antibody positive (result of Detected) are not eligible for treatment with ROCTAVIAN; patients that are anti-AAV5 antibody negative (result of Not Detected) are eligible for treatment with ROCTAVIAN. This assay is for professional use and is a single-site assay performed at ARUP Laboratories.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QWQ | Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors | FDA class 3 | Unknown |