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510(k) DEN180014

WOUNDCHEK Bacterial Status by Alere Scarborough, Inc. — Product Code QFA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 2, 2019
Date Received
March 23, 2018
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay For Detection Of Proteases In Chronic Wounds
Device Class
Class II
Regulation Number
866.3231
Review Panel
MI
Submission Type

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.

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