AAV5 DetectCDx
FDA premarket approval P190033 · decided 2023-06-29
Approval details
- PMA number
- P190033
- Trade name
- AAV5 DetectCDx
- Generic name
- Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
- Applicant
- ARUP Laboratories
- Date received
- 2019-12-23
- Decision date
- 2023-06-29
- Days to decision
- 1284 days
- Decision code
- APWD
- Product code
- QWQ
- Advisory committee
- Hematology
- Expedited review
- No
- Location
- Salt Lake City, UT
- 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 o
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.