BIOFIRE FILMARRAY Tropical Fever Panel

The BIOFIRE FILMARRAY Tropical Fever Panel is an automated PCR-based test that detects bacterial, viral, and parasitic nucleic acids directly from EDTA whole blood in patients with acute febrile illness. It identifies six target pathogens: chikungunya virus, dengue virus (serotypes 1-4), Leptospira spp., and Plasmodium spp. (with species differentiation), delivering results in approximately 50 minutes on BIOFIRE 2.0 or TORCH Systems.

The device uses nested multiplex PCR followed by high-resolution melting analysis to confirm amplified product identity. Sample processing is automated within the BIOFIRE System using mechanical and chemical lysis followed by magnetic bead-based purification. Two internal controls monitor sample processing and both PCR stages. Reagents are freeze-dried and stored at room temperature with a 12-month shelf-life. Test interpretation is fully automated with no user access to raw data.

Not stated in this summary.

The BIOFIRE FILMARRAY TF Panel is a rebranded version of the legally marketed BioFire Global Fever Panel (K220870) with identical performance claims, organisms detected, specimen types, technological principles, instrumentation, time-to-result, and controls. The only modifications are updated pouch module software (verified and validated to show no change in safety and effectiveness), new instructions for use, updated product labeling, and rebranding—none of which alter the fundamental scientific technology, performance characteristics, or risk profile of the device.