# K220870: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Defense, LLC
- Decided: Oct 20, 2022 after 209 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
Longest line of descent: 4 generations back to DEN150058 (2016). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200043: FilmArray Global Fever Panel, Biofire Defense, LLC (2020) Summary page 4.
- K202382: FilmArray Global Fever Panel External Control Kit, Biofire Defense, LLC (2020) Summary page 4.

## Most influential descendants
- K261475: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (2026), 0 descendants of its own
- K243463: BIOFIRE FILMARRAY Tropical Fever Panel (2024), 0 descendants of its own

## Indications for use
The BioFire® Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire 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: chikungunya virus, dengue virus (serotypes 1, 2, 3 and 4), Leptospira spp., 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 BioFire 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. In the United States, patient travel history and consultation of the CDC Yellow Book should be considered prior to use of the BioFire Global Fever Panel as some pathogens are more common in certain geographical locations. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K220870
Methodology: https://510kreport.com/methodology