# K202382: FilmArray Global Fever Panel External Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Defense, LLC
- Decided: Nov 20, 2020 after 92 days
- Product code: PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN150058 (2016). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163522: FilmArray Warrior Control Panel M290, Maine Molecular Quality Controls, Inc. (2017) Summary page 4.

## Most influential descendants
- K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (2023), 2 descendants of its own
- K220870: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (2022), 2 descendants of its own
- K253653: Xpert Hemorrhagic Fever (2026), 1 descendant of its own
- K261362: Xpert Hemorrhagic Fever (2026), 0 descendants of its own
- K261475: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K202382
Methodology: https://510kreport.com/methodology