# K261475: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Defense, LLC
- Decided: Jul 17, 2026 after 73 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: 5 generations back to DEN150058 (2016). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220870: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel, Biofire Defense, LLC (2022) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K261475
Methodology: https://510kreport.com/methodology