Assay For Detection Of Proteases In Chronic Wounds
The Assay For Detection Of Proteases In Chronic Wounds is a lateral flow prescription diagnostic device, which may include a sterile swab, intended as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers by detecting bacterial protease activity in wound fluid in patients without signs of active wound infection. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.3231 in the Microbiology specialty. The product code is QFA. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFA
- Device Class
- FDA class 2
- Regulation Number
- 866.3231
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN180014 | WOUNDCHEK Bacterial Status | Dec 02, 2019 | Unknown | Alere Scarborough, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.