Not Cleared Direct

DEN180014 - WOUNDCHEK Bacterial Status (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180014 · Alere Scarborough, Inc. · Microbiology device
Dec 2019
Decision
619d
Days
Class 2
Risk

DEN180014 is an FDA 510(k) submission (not cleared) for the WOUNDCHEK Bacterial Status. Classified as Assay For Detection Of Proteases In Chronic Wounds (product code QFA), Class II - Special Controls.

Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Not Cleared (DENG) decision on December 2, 2019 after a review of 619 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3231 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 619 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

Submission Details

510(k) Number DEN180014 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 23, 2018
Decision Date December 02, 2019
Days to Decision 619 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Regulatory Context
Review time vs. panel average
445d slower than avg
Panel avg: 174d · This submission: 619d
Pathway characteristics

Device Classification

Product Code QFA Assay For Detection Of Proteases In Chronic Wounds
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3231
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.