510(k) · Cleared
ClearedBioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Defense, LLC · QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
Cleared on Mar 22, 2023 as substantially equivalent to DEN200043 (Biofire Defense, LLC, 2020) and 2 other predicates after a 526-day review. Its family tree reaches back 4 generations to 2016. 2 later devices descend from it.
- Decided
- Mar 22, 2023
- Review
- 526 days
- Class
- Class II
- Product code
- QVR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to DEN150058 (2016). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 3 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 2 generations backK163522 FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017
- 1 generation backK202382 FilmArray Global Fever Panel External Control KitBiofire Defense, LLC · 2020
- This deviceK213362 BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control…Biofire Defense, LLC · 2023
- Descendant · cites it directly · 1 of its ownK253653 Xpert Hemorrhagic FeverCepheid · 2026
- Descendant · 2 generations on · 0 of its ownK261362 Xpert Hemorrhagic FeverCepheid · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −3 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −2 | K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017 | — |
| −1 | K202382 | FilmArray Global Fever Panel External Control Kit | Biofire Defense, LLC | 2020 | — |
| 0 (this device) | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for… | Biofire Defense, LLC | 2023 | — |
| +1 | K253653 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
| +2 | K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA 510(k) 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 QVR? 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 QVR device
- #1 K261362 Xpert Hemorrhagic Feverscore 13.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200043 | FilmArray Global Fever PanelSummary page 5…for biothreat agents Regulatory Class: Class II (Special Controls) Panel: Microbiology – 83 III. Predicate Devices BioFire® Global Fever Panel (BioFire Defense, LLC) [DEN200043] This predicate has not been subject to a design-related recall. FilmArray® NGDS Warrior Panel (BioFire Defense, LLC) [K170883]… | 2020 |
| * | K170883 | FilmArray NGDS Warrior PanelSummary page 5…bal Fever Panel (BioFire Defense, LLC) [DEN200043] This predicate has not been subject to a design-related recall. FilmArray® NGDS Warrior Panel (BioFire Defense, LLC) [K170883] This predicate has not been subject to a design-related recall. BioFire® Global Fever Special Pathogens Panel 510(k) Summ… | 2017 |
| * | K202382 | FilmArray Global Fever Panel External Control KitSummary page 37…gulatory Class: Class II (Special Controls) Panel: Microbiology – 83 Predicate Device: BIOFIRE® SHIELD™ Control Kit for the Global Fever Panel (BioFire Defense, LLC) [K202382] This predicate has not been subject to a design-related recall. Device Description The BIOFIRE SHIELD Control Kit for th… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253653 | Xpert Hemorrhagic Fever | 2026 | 1 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K253653 (Cepheid, 2026) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate DEN200043.
How does its category compare?
All QVR devicesQVR Multiplex Nucleic Acid Detection System For Biothreat Agents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVR
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVR
Too few QVR 510(k)s in any year since 2007 to give a median.
Recalls per year · QVR
No recall names QVR since 2007.
Adverse event reports per year · QVR
No MAUDE report names QVR 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 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (414 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213362
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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