Cleared Special

K243463 - BIOFIRE FILMARRAY Tropical Fever Panel (FDA 510(k) Clearance)

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

K243463 · Biofire Diagnostics, LLC (Biomerieux) · Microbiology device
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Dec 2024
Decision
27d
Days
Class 2
Risk

K243463 is an FDA 510(k) clearance for the BIOFIRE FILMARRAY Tropical 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 Diagnostics, LLC (Biomerieux) (Salt Lake City, US). The FDA issued a Cleared decision on December 5, 2024 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3966 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biofire Diagnostics, LLC (Biomerieux) devices

Submission Details

510(k) Number K243463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date December 05, 2024
Days to Decision 27 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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.