510(k) · Cleared
ClearedBIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Defense, LLC · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on Jul 17, 2026 as substantially equivalent to K220870 (Biofire Defense, LLC, 2022) after a 73-day review. Its family tree reaches back 5 generations to 2016.
- Decided
- Jul 17, 2026
- Review
- 73 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN150058 (2016). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 4 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 3 generations backK163522 FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017
- 2 generations backK202382 FilmArray Global Fever Panel External Control KitBiofire Defense, LLC · 2020
- 1 generation backK220870 BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the…Biofire Defense, LLC · 2022
- This deviceK261475 BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −4 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −3 | K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017 | — |
| −2 | K202382 | FilmArray Global Fever Panel External Control Kit | Biofire Defense, LLC | 2020 | — |
| −1 | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global… | Biofire Defense, LLC | 2022 | — |
| 0 (this device) | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 PMN? 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 PMN device
- #1 K251526 FilmArray GI Control Panel M238score 13.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelSummary page 5…de: PMN Regulatory Class: Class II (Special Controls) Panel: Microbiology – 83 III. Predicate Device BIOFIRE® SHIELDTM Control Kit for the BioFire Global Fever Panel [K220870] This predicate device has not been subject to a design-related recall. IV. Device Description The BIOFIRE FILMARRAY Tropical… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K220870.
How does its category compare?
All PMN devicesPMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PMN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMN
90in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PMN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMN
1in 2023
MAUDE reports naming product code PMN, not matched to any one device; reports are not rates.
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 | 3 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 59 | 0 | 0 |
| 2019 | 6 | 71 | 1 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 582 | 0 | 0 |
| 2023 | 4 | 90 | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 85 | 0 | — |
What is it indicated for?
The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit contains Positive and Negative External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of chikungunya virus, dengue virus (serotypes 1, 2, 3, and 4), Leptospira spp., and Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium…
Read the full statement (184 words)
The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit contains Positive and Negative External Controls intended
for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing
procedures for the qualitative detection of 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) when using
the BIOFIRE FILMARRAY Tropical Fever Panel on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY
TORCH Systems. The BIOFIRE FILMARRAY Tropical Fever Panel Control Kit is designed for and intended to be used
solely with the BIOFIRE FILMARRAY Tropical Fever Panel. This product does not replace manufacturer internal
controls provided as part of the BIOFIRE FILMARRAY Tropical Fever Panel.
Both the Positive and Negative External Controls are provided in a Control Injection Vial format. The Positive Control
Injection Vial contains dried synthetic nucleic acid segments in buffer and stabilizer to assess for the presence of each
individual assay on the BIOFIRE FILMARRAY Tropical Fever Panel. The Negative Control Injection Vial is non-
reactive with the BIOFIRE FILMARRAY Tropical Fever Panel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261475: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261475
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026