FDA product code QWQ: Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
QWQ is the FDA product code for assays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors. It is a Class III device, reviewed by the Immunology panel. Devices under QWQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
An in vitro diagnostic device intended to detect and/or measure pre-existing endogenous antibodies to adeno-associated virus (AAV) viral vectors in patients who may receive AAV vector-based gene therapy products.
Classification
| Field | Value |
|---|---|
| Device name | Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QWQ devices
openFDA lists no recalls for product code QWQ.
Frequently asked questions
What is FDA product code QWQ?
QWQ is the FDA product code for assays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectors. It is a Class III device, reviewed by the Immunology panel.
What device class is QWQ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QWQ
- Run a recall and safety report across every QWQ manufacturer
- Watch product code QWQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.