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BioFire FilmArray Tropical Fever Panel

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243463

by Biofire Diagnostics, LLC (Biomerieux)

Identifiers

510(k) Number
K243463 FDA 510(k)
FDA Product Code
QMV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3966 FDA 510(k)
Regulation Number
866.3966 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BioFire FilmArray Tropical Fever Panel is a Device to Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness, classified under FDA regulation 866.3966. This syndromic multiplex PCR assay simultaneously detects and differentiates six bacterial, viral, and parasitic pathogens linked to tropical fever syndromes, enabling rapid and targeted diagnostic evaluation.

This in vitro diagnostic device is intended for use in microbiology laboratories and clinical settings requiring rapid pathogen identification. Supplied as a single-use, automated cartridge, it requires connection to the FilmArray® system for processing and results interpretation within approximately 50 minutes. The device is not MRI-compatible and must be stored under controlled conditions as specified in the manufacturer’s instructions. Its regulatory clearance is granted under FDA 510(k) Special Review (K243463, QMV product code)

Frequently asked questions

What pathogens does the BIOFIRE FILMARRAY Tropical Fever Panel detect?

This multiplex PCR assay simultaneously detects and differentiates six bacterial, viral, and parasitic pathogens linked to tropical fever syndromes, enabling rapid diagnostic evaluation.

How is the BIOFIRE FILMARRAY Tropical Fever Panel supplied and used?

The device is supplied as a single-use, automated cartridge that requires connection to the FilmArray® system for processing and results interpretation, which takes approximately 50 minutes.

What are the storage requirements for the BIOFIRE FILMARRAY Tropical Fever Panel?

The device must be stored under controlled conditions as specified in the manufacturer's instructions, and it is not MRI-compatible.

What is the regulatory clearance status of the BIOFIRE FILMARRAY Tropical Fever Panel?

The device has FDA 510(k) Special Review clearance with K number K243463 and QMV product code, classified under FDA regulation 866.3966.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BIOFIRE® FILMARRAY® TROPICAL FEVER (TF) PANEL - biomerieux.com, Product: BioFire FilmArray Tropical Fever Panel - 424803, BIOFIRE® FILMARRAY® Tropical Fever Panel, a syndromic PCR test ..., PDF December 5, 2024 BioFire Diagnostics, LLC (bioMerieux) Karli Plenert Sr ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biofire Diagnostics, LLC (Biomerieux)

Sources (1)

  • FDA 510(k) K243463 24 fields · synced Sep 19, 2026