FDA product code QRF: Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
QRF is the FDA product code for multi-analyte test system with algorithmic analysis for detection of prostate cancer. It is a Class III device, reviewed by the Immunology panel. Devices under QRF reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 2 recalls for QRF devices, 2 initiated in the last five years.
Definition
Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy.
Classification
| Field | Value |
|---|---|
| Device name | Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer |
| Device class | Class III |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QRF devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-10-31.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code QRF?
QRF is the FDA product code for multi-analyte test system with algorithmic analysis for detection of prostate cancer. It is a Class III device, reviewed by the Immunology panel.
What device class is QRF?
Class III. Typical premarket route: PMA.
Have QRF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code QRF
- Run a recall and safety report across every QRF manufacturer
- Watch product code QRF 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.
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