510(k) · Cleared

Cleared

FilmArray GI Control Panel M238

K251526510(k) TraditionalCleared Aug 14, 202587-day reviewClass II21 CFR 866.3920

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Maine Molecular Quality Controls, Inc. · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Cleared on Aug 14, 2025 as substantially equivalent to K202196 (Maine Molecular Quality Controls, Inc., 2021) after an 87-day review. Its family tree reaches back 4 generations to 2016. 1 later device descends from it.

Decided: Aug 14, 2025
Review: 87 days
Class: Class II
Product code: PMN
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to DEN150058 (2016). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
3 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
2 generations backK173171 FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017
1 generation backK202196 BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc. · 2021
This deviceK251526 FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc. · 2025
Descendant · cites it directly · 0 of its ownK260577 FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all

K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	DEN150058	Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level…	Bio-Rad Laboratories	2016	—
−3	K161573	FilmArray RP EZ Control Panel M265	Maine Molecular Quality Controls, Inc.	2016	—
−2	K173171	FilmArray RP2/RP2plus Control Panel	Maine Molecular Quality Controls, Inc.	2017	—
−1	K202196	BioFire RP2.1/RP2.1plus Control Panel M441	Maine Molecular Quality Controls, Inc.	2021	—
0 (this device)	K251526	FilmArray GI Control Panel M238	Maine Molecular Quality Controls, Inc.	2025	—
+1	K260577	FilmArray TF Control Panel M527	Maine Molecular Quality Controls, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K251526, 2016–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K261475 BIOFIRE® FILMARRAY® Tropical Fever Panel…score 12.9 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K202196	BioFire RP2.1/RP2.1plus Control Panel M441 Summary page 5 …Class II (Special controls) Regulation: 21 CFR 866.3920 Product code: PMN Predicate Device K202196; BioFire® RP2.1/RP2.1plus Control Panel Device Description FilmArray GI Control Panel M238, P/N M238, is a quality control panel…	Maine Molecular Quality Controls, Inc.	2021	—

Also cleared against K202196: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K260577	FilmArray TF Control Panel M527	Maine Molecular Quality Controls, Inc.	2026	0

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 9 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K260577 (Maine Molecular Quality Controls, Inc., 2026) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K202196.

How does its category compare?

All PMN devices

PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · PMN

1in 2025

2007high 6 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PMN

90in 2023

2007high 582 (2022) · low 59 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PMN

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PMN

1in 2023

2007high 1 (2023) · low 0 (2007)2025

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?

Read the full statement (184 words)

The FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on the BIOFIRE FILMARRAY systems. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays qualitatively detect the following targets: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) It/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. The FilmArray GI Control Panel M238 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE FILMARRAY GI Panel and the BIOFIRE FILMARRAY GI Panel Mid assays. This product is not intended to replace manufacturer internal controls provided with these devices.

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/K251526 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251526: FilmArray GI Control Panel M238.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251526

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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