# K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Defense, LLC
- Decided: Mar 22, 2023 after 526 days
- Product code: QVR (Multiplex Nucleic Acid Detection System For Biothreat Agents)
- Device class: 2
- Regulation: 21 CFR 866.4000
- 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). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 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 5.
- K170883: FilmArray NGDS Warrior Panel, Biofire Defense, LLC (2017) Summary page 5.
- K202382: FilmArray Global Fever Panel External Control Kit, Biofire Defense, LLC (2020) Summary page 37.

## Most influential descendants
- K253653: Xpert Hemorrhagic Fever (2026), 1 descendant of its own
- K261362: Xpert Hemorrhagic Fever (2026), 0 descendants of its own

## Indications for use
The BioFire® Global Fever Special Pathogens Panel is a qualitative, multiplexed, nucleic acid-based test intended for use with BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire Global Fever Special Pathogens Panel is for the simultaneous qualitative detection and identification of multiple 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 target pathogens described below. Pathogens identified: Chikungunya virus Dengue virus (serotypes 1, 2, 3 and 4) Leishmania spp. that cause visceral leishmaniasis (e.g., L. donovani and L. infantum) Leptospira spp. Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale) West Nile virus Pathogens presumptively identified: Bacillus anthracis Crimean-Congo hemorrhagic fever virus Ebolavirus spp. Francisella tularensis Lassa virus Marburgvirus Yellow fever virus Yersinia pestis Pathogens for which the panel provides presumptive identification results require additional testing and confirmation procedures in consultation with the appropriate public health authorities for whom reports may be necessary. Positive results do not rule out co-infections with pathogens not included on the BioFire Global Fever Special Pathogens Panel. Not all pathogens that cause acute febrile illness are detected by this test, and negative results do not preclude infection with the pathogens targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. 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. In the United States, patient travel history, exposure risk, and consultation of the CDC Yellow Book should be considered prior to use of the BioFire Global Fever Special Pathogens Panel as some pathogens are more common in certain geographical locations. 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. The BioFire Global Fever Special Pathogens Panel is indicated for use in laboratories having appropriate biosafety equipment, personal protective equipment (PPE), containment facilities and personnel trained in the safe handling of diagnostic clinical specimens potentially containing any of the pathogens detected by this panel. The BioFire Global Fever Special Pathogens Panel is indicated for use in laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.

Source page: https://510kreport.com/device/K213362
Methodology: https://510kreport.com/methodology