QFA

Assay For Detection Of Proteases In Chronic Wounds

Product code

QFA

Device name

Assay For Detection Of Proteases In Chronic Wounds

Device class

Class 2

21 CFR

21 CFR 866.3231

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).