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U.S. Department of Health and Human Services

Product Classification

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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 CodeQFA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
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