510(k) DEN180014
DEN180014 is an FDA 510(k) premarket notification submitted by Alere Scarborough, Inc. for the device "WOUNDCHEK Bacterial Status". The FDA issued a decision of De Novo Granted on December 2, 2019. The device falls under product code QFA (Assay For Detection Of Proteases In Chronic Wounds), a Class II device regulated under 21 CFR 866.3231. Alere Scarborough, Inc. has at least 10 other 510(k) clearances on record.
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.