QFA — Assay For Detection Of Proteases In Chronic Wounds Class II
Classification Details
- Product Code
- QFA
- Device Class
- Class II
- Regulation Number
- 866.3231
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180014 | alere scarborough | WOUNDCHEK Bacterial Status | December 2, 2019 |