Device |
assay for detection of proteases in chronic wounds |
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. |
Physical State |
Swab to collect wound fluid that is then mixed with a substrate and added to a lateral flow device for detection of enzymatic activity |
Technical Method |
Detection of enzymatic activity |
Target Area |
Various - Skin (chronic wounds) |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QFA |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3231
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |