FDA product code QFA: Assay For Detection Of Proteases In Chronic Wounds
QFA is the FDA product code for assay for detection of proteases in chronic wounds. It is a Class II device, regulated under 21 CFR 866.3231 and reviewed by the Microbiology panel. Devices under QFA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A device to detect bacterial protease activity in chronic wound fluid is a lateral flow prescription device that may include a sterile swab. The device is intended for use in patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patient are asymptomatic for clinical signs of infection.
Classification
| Field | Value |
|---|---|
| Device name | Assay For Detection Of Proteases In Chronic Wounds |
| Device class | Class II |
| Regulation | 21 CFR 866.3231 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QFA devices
openFDA lists no recalls for product code QFA.
Frequently asked questions
What is FDA product code QFA?
QFA is the FDA product code for assay for detection of proteases in chronic wounds. It is a Class II device, regulated under 21 CFR 866.3231 and reviewed by the Microbiology panel.
What device class is QFA?
Class II, regulation 21 CFR 866.3231. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QFA
- Run a recall and safety report across every QFA manufacturer
- Watch product code QFA 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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