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| Device | AAV5 DetectCDx |
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| Generic Name | Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors |
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| Applicant | ARUP Laboratories
500 Chipeta Way
Salt Lake City, UT 84108 |
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| PMA Number | P190033 |
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| Date Received | 12/23/2019 |
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| Decision Date | 06/29/2023 |
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| Product Code |
QWQ |
| Docket Number | 23M-3055 |
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| Notice Date | 09/18/2023 |
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| Advisory Committee |
Hematology |
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| Clinical Trials | NCT03370913
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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