# K260577: FilmArray TF Control Panel M527

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: May 19, 2026 after 88 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251526: FilmArray GI Control Panel M238, Maine Molecular Quality Controls, Inc. (2025) Summary page 5.

## Indications for use
The FilmArray TF Control Panel M527 is intended for use as an external positive and negative assayed quality control to monitor the performance of the BIOFIRE FILMARRAY Tropical Fever (TF) Panel assay on the BIOFIRE FILMARRAY Systems. The BIOFIRE FILMARRAY TF Panel assay qualitatively detects the following target pathogens: chikungunya virus, dengue virus (serotypes 1, 2, 3, and 4), Leptospira spp., Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale). The FilmArray TF Positive control is composed of synthetic DNA and RNA in stabilizing solutions, buffers, and preservatives. The FilmArray TF Negative control contains buffers and preservatives. The FilmArray TF Control Panel M527 is designed for and intended to be used solely with the BIOFIRE FILMARRAY TF Panel. This product is not intended to replace manufacturer internal controls provided with this device.

Source page: https://510kreport.com/device/K260577
Methodology: https://510kreport.com/methodology