510(k) · Cleared
ClearedFilmArray Global Fever Panel External 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 Nov 20, 2020 as substantially equivalent to K163522 (Maine Molecular Quality Controls, Inc., 2017) after a 92-day review. Its family tree reaches back 3 generations to 2016. 6 later devices descend from it.
- Decided
- Nov 20, 2020
- Review
- 92 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150058 (2016). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 2 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 1 generation backK163522 FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017
- This deviceK202382 FilmArray Global Fever Panel External Control KitBiofire 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 |
|---|---|---|---|---|---|
| −3 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −2 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −1 | K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017 | — |
| 0 (this device) | K202382 | FilmArray Global Fever Panel External Control Kit | 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 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 |
|---|---|---|---|
| * | K163522 | FilmArray Warrior Control Panel M290Summary page 4…920 Panel: Microbiology - 83 Product code: PMN Predicate Device FilmArray Warrior Control Panel M290 (K163522) Device Description The FilmArray Global Fever Panel External Control Kit contains Positive and Negative External Controls. The… | 2017 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K213362 (Biofire Defense, LLC, 2023) has gone furthest, with 2 descendants of its own.
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. 2020, 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 FilmArray® Global Fever Panel External 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 FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global…
Read the full statement (148 words)
The FilmArray® Global Fever Panel External 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 FilmArray® Global Fever Panel targets on FilmArray® 2.0 systems. The Global Fever Panel External Control Kit is designed for and intended to be used solely with the FilmArray Global Fever Panel. This product does not replace manufacturer internal controls provided as part of the Global Fever Panel device.
Both the Positive and Negative External Controls are provided in a FilmArray Control Injection Vial format. The Positive Control Injection Vial contains dried synthetic DNA segments in buffer and stabilizer to assess the presence of each individual assay on the FilmArray Global Fever Panel. The Negative Control Injection Vial contains no DNA, and is non-reactive with the Global Fever Panel assays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202382: FilmArray Global Fever Panel External 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/K202382
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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