Last synced on 6 December 2024 at 11:05 pm

Assay For Detection Of Proteases In Chronic Wounds

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3231
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QFA is linked to regulation 21CFR866.3231, which does not seem to exist yet. It may be pending at the moment.

Assay For Detection Of Proteases In Chronic Wounds

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3231
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QFA is linked to regulation 21CFR866.3231, which does not seem to exist yet. It may be pending at the moment.