510(k) · Cleared
ClearedFilmArray TF Control Panel M527
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Molecular Quality Controls, Inc. · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on May 19, 2026 as substantially equivalent to K251526 (Maine Molecular Quality Controls, Inc., 2025) after an 88-day review. Its family tree reaches back 5 generations to 2016.
- Decided
- May 19, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN150058 (2016). 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 backK173171 FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017
- 2 generations backK202196 BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc. · 2021
- 1 generation backK251526 FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc. · 2025
- This deviceK260577 FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc. · 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 | K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | 2017 | — |
| −2 | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021 | — |
| −1 | K251526 | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | 2025 | — |
| 0 (this device) | K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K251526 | FilmArray GI Control Panel M238Summary page 5…Class II (Special controls) Regulation: 21 CFR 866.3920 Product code: PMN Predicate Device K251526; FilmArray GI Control Panel M238 Device Description The FilmArray TF Control Panel M527, P/N M527, is a quality control panel co… | 2025 |
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 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
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 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…
Read the full statement (134 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260577: FilmArray TF Control Panel M527.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260577
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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