Cleared Traditional

FilmArray GI Control Panel M238

K251526 · Maine Molecular Quality Controls, Inc. · Microbiology

Aug 2025

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K251526 is an FDA 510(k) clearance for the FilmArray GI Control Panel M238, a Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (Class II — Special Controls, product code PMN), submitted by Maine Molecular Quality Controls, Inc. (Saco, US). The FDA issued a Cleared decision on August 14, 2025, 87 days after receiving the submission on May 19, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K251526 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2025
Decision Date	August 14, 2025
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3920
Definition	Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.