# DEN200043: FilmArray Global Fever Panel

- Pathway: De Novo (Direct)
- Applicant: Biofire Defense, LLC
- Decided: Nov 20, 2020 after 147 days
- Product code: QMV (Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness)
- Device class: 2
- Regulation: 21 CFR 866.3966
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (2023), 2 descendants of its own
- K220870: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (2022), 2 descendants of its own
- K253653: Xpert Hemorrhagic Fever (2026), 1 descendant of its own
- K261362: Xpert Hemorrhagic Fever (2026), 0 descendants of its own
- K261475: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (2026), 0 descendants of its own

## Indications for use
The FilmArray Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens: Leptospira spp., chikungunya virus, dengue virus (serotypes 1, 2, 3 and 4), and Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale). Evaluation for more common causes of acute febrile illness (e.g., infections of the upper and lower respiratory tract or gastroenteritis, as well as non-infectious causes) should be considered prior to evaluation with this panel. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. Positive results do not rule out co-infections with pathogens not included on the FilmArray Global Fever Panel. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not rule out the presence of other infections. Patient travel history and consultation of the CDC Yellow Book should be considered prior to use of the FilmArray Global Fever Panel as some pathogens are more common in certain geographical locations.

Source page: https://510kreport.com/device/DEN200043
Methodology: https://510kreport.com/methodology