De Novo · Granted
GrantedFilmArray Global Fever Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Defense, LLC · QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Granted on Nov 20, 2020 as a new device type through De Novo after a 147-day review. 6 later devices descend from it.
- Decided
- Nov 20, 2020
- Review
- 147 days
- Class
- Class II
- Product code
- QMV
- Recalls
- None
6 later devices descend from it, 2 citing it directly.
- This deviceDEN200043 FilmArray Global Fever PanelBiofire Defense, LLC · 2020
- Descendant · cites it directly · 2 of its ownK213362 BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control…Biofire Defense, LLC · 2023
- Descendant · cites it directly · 2 of its ownK220870 BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the…Biofire Defense, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK253653 Xpert Hemorrhagic FeverCepheid · 2026
- Descendant · 3 generations on · 0 of its ownK261362 Xpert Hemorrhagic FeverCepheid · 2026
- Descendant · 2 generations on · 0 of its ownK261475 BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…Biofire Defense, LLC · 2023 · cites it directly2descendants
- K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelBiofire Defense, LLC · 2022 · cites it directly2descendants
- K253653Xpert Hemorrhagic FeverCepheid · 2026 · 2 generations on1descendant
- K261362Xpert Hemorrhagic FeverCepheid · 2026 · 3 generations on0descendants
- K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200043 | FilmArray Global Fever Panel | Biofire Defense, LLC | 2020 | — |
| +1 | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for… | Biofire Defense, LLC | 2023 | — |
| +1 | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global… | Biofire Defense, LLC | 2022 | — |
| +2 | K253653 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
| +3 | K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
| +2 | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QMV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QMV device
- #1 K220870 BioFire Global Fever Panel, BIOFIRE SHIELD…score 11.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K213362 (Biofire Defense, LLC, 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QMV devicesQMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QMV
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QMV
Too few QMV 510(k)s in any year since 2007 to give a median.
Recalls per year · QMV
No recall names QMV since 2007.
Adverse event reports per year · QMV
No MAUDE report names QMV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (228 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200043 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200043: FilmArray Global Fever Panel.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200043
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026