Identity
- Trade Name
- AAV5 DetectCDx FDA PMA
- Generic Name
- Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors FDA PMA
Identifiers
- PMA Number
- P190033 FDA PMA
- FDA Product Code
- QWQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Hematology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The AAV5 DetectCDx is a qualitative in vitro diagnostic test classified as an assay to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors. It employs electrochemiluminescence to identify antibodies in human plasma collected in 3.2% sodium citrate that bind to AAV serotype 5, aiding in patient eligibility assessment for ROCTAVIAN (valoctocogene roxaparvovec-rvox) treatment in hemophilia A.
This assay is intended for professional use and is performed exclusively at ARUP Laboratories as a single-site test. Supplied as a reagent kit, it requires plasma samples collected in 3.2% sodium citrate tubes and is not intended for reuse. The device holds FDA Premarket Approval (PMA) under PMA number P190033, with regulatory classification as a Class III device under product code QWQ.
Frequently asked questions
What is the AAV5 DetectCDx used for in clinical practice and how does it help patients with hemophilia A?
The AAV5 DetectCDx is a qualitative in vitro diagnostic test that detects pre-existing antibodies to adeno-associated virus (AAV) serotype 5 in human plasma. It uses electrochemiluminescence to identify if a patient has antibodies that could interfere with ROCTAVIAN (valoctocogene roxaparvovec-rvox), a gene therapy treatment for hemophilia A. If antibodies are detected, the patient is not eligible for ROCTAVIAN, as these antibodies may neutralize the therapy’s effectiveness. If no antibodies are found, the test supports eligibility for treatment.
How is the AAV5 DetectCDx supplied and what type of sample is required for testing?
The AAV5 DetectCDx is supplied as a reagent kit designed for professional use at ARUP Laboratories. It requires plasma samples collected specifically in **3.2% sodium citrate tubes**—this is a critical requirement for accurate testing. The test is not intended for reuse and must be performed exclusively at ARUP Laboratories as a single-site assay.
Is the AAV5 DetectCDx a single-use or reusable device, and how should it be handled?
The AAV5 DetectCDx is **not intended for reuse**. It is supplied as a reagent kit for professional use at ARUP Laboratories, meaning each test run uses a fresh kit component. Since it is a single-site assay, the device itself is not physically reusable—only the plasma samples (collected in citrate tubes) are processed through the kit. Proper handling involves adhering to the manufacturer’s instructions for plasma collection and kit usage to ensure accurate results.
What regulatory pathway does the AAV5 DetectCDx follow, and what does its classification as a Class III device mean?
The AAV5 DetectCDx received **FDA Premarket Approval (PMA)** under PMA number **P190033**, classifying it as a **Class III device** under product code **QWQ**. This designation reflects its role as a high-risk medical device due to its use in determining eligibility for a critical gene therapy (ROCTAVIAN). The PMA approval ensures the device meets stringent regulatory standards for safety and effectiveness before clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190033 | Class III | Active |
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Manufacturer
- Manufacturer
- ARUP Laboratories
Sources (1)
- FDA PMA P190033 24 fields · synced Sep 18, 2026