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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAAV5 DetectCDx
Generic NameAssays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
ApplicantARUP Laboratories
500 Chipeta Way
Salt Lake City, UT 84108
PMA NumberP190033
Date Received12/23/2019
Decision Date06/29/2023
Product Code QWQ 
Docket Number 23M-3055
Notice Date 09/18/2023
Advisory Committee Hematology
Clinical TrialsNCT03370913
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness