Assay For Detection Of Proteases In Chronic Wounds
QFA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3231
Classification
FDA Product Code
QFA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3231
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.