Cleared Traditional

K251526 - FilmArray GI Control Panel M238 (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251526 · Maine Molecular Quality Controls, Inc. · Microbiology device
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Aug 2025
Decision
87d
Days
Class 2
Risk

K251526 is an FDA 510(k) clearance for the FilmArray GI Control Panel M238. Classified as Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (product code PMN), Class II - Special Controls.

Submitted by Maine Molecular Quality Controls, Inc. (Saco, US). The FDA issued a Cleared decision on August 14, 2025 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3920 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maine Molecular Quality Controls, Inc. devices

Submission Details

510(k) Number K251526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

All 29
Devices cleared under the same product code (PMN) and FDA review panel - the closest regulatory comparables to K251526.
MDx-Chex for BCP
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MDx-Chex for BCN
K254166 · Streck · Mar 2026
MDx-Chex for BCY
K254167 · Streck, LLC · Mar 2026
SPOTFIRE RSP Pos & Neg Controls
K241289 · Maine Molecular Quality Controls, Inc. · May 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
K233611 · Maine Molecular Quality Controls, Inc. · Mar 2024
MDx-Chex for BC-GP
K231221 · Streck · Jul 2023