# DEN180014: WOUNDCHEK Bacterial Status

- Pathway: De Novo (Direct)
- Applicant: Alere Scarborough, Inc.
- Decided: Dec 2, 2019 after 619 days
- Product code: QFA (Assay For Detection Of Proteases In Chronic Wounds)
- Device class: 2
- Regulation: 21 CFR 866.3231
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
WOUNDCHEK Bacterial Status (WCBS) is an in vitro diagnostic chromatographic test for the qualitative detection of bacterial protease activity directly from wound fluid samples collected with a swab. The WCBS test is intended for use in adult 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 patients are asymptomatic for clinical signs of infection. The test is intended for use with chronic wounds that are between 21 days and < 6 months of age and chronic wounds that are ≥ 6 months of age that are < 1cm2 in size. This test is indicated for use solely by health care professionals whose clinical practice primarily or routinely involves the assessment and treatment of chronic wounds. WCBS results are intended for use in conjunction with the assessment of other known risk factors for wound healing that significantly contribute to the assessment of risk for non-healing chronic wounds such as wound age, wound size, and vascular status.

Source page: https://510kreport.com/device/DEN180014
Methodology: https://510kreport.com/methodology