| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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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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| Supplements: |
S001 |
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