Not Cleared Direct

DEN200043 - FilmArray Global Fever Panel (FDA 510(k) Clearance)

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

DEN200043 · Biofire Defense, LLC · Microbiology device
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Nov 2020
Decision
147d
Days
Class 2
Risk

DEN200043 is an FDA 510(k) submission (not cleared) for the FilmArray Global Fever Panel. Classified as Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness (product code QMV), Class II - Special Controls.

Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on November 20, 2020 after a review of 147 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3966 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

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Submission Details

510(k) Number DEN200043 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 26, 2020
Decision Date November 20, 2020
Days to Decision 147 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 102d · This submission: 147d
Pathway characteristics

Device Classification

Product Code QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3966
Definition A Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness Is Identified As A In Vitro Device Intended For The Detection And Identification Of Microbial Agents In Human Clinical Specimens From Patients With Signs And Symptoms Of Acute Febrile Illness Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. It Is Intended To Aid In The Diagnosis Of Acute Febrile Illness In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data, Including Patient Travel, Pathogen Endemicity, Or Other Risk Factors.
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.