Cleared Traditional

K263232 - eplex RP3 Control M530

Also marketed or referenced as:

eplex RP3 Negative

K263232 is an FDA 510(k) clearance for eplex RP3 Control M530, manufactured by Maine Molecular Quality Controls, Inc.. The device is a Class 2 Microbiology device with product code PMN cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K263232 · Maine Molecular Quality Controls, Inc. · Microbiology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Oct 2026

Decision

44d

Days

Class 2

Risk

K263232 is an FDA 510(k) clearance for the eplex RP3 Control M530. 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 October 30, 2026 after a review of 44 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.

FDA 510(k) Submission Details - K263232

510(k) Number	K263232 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 16, 2026
Decision Date	October 30, 2026
Days to Decision	44 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

58d faster than avg

Panel avg: 102d · This submission: 44d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

PMN Device Classification - Class 2, Special Controls

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 33

Devices cleared under the same product code (PMN) and FDA review panel - the closest regulatory comparables to K263232.

SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control

K262573 · Maine Molecular Quality Controls, Inc. · Oct 2026

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

K261475 · Biofire Defense, LLC · Jul 2026

FilmArray TF Control Panel M527

K260577 · Maine Molecular Quality Controls, Inc. · May 2026

MDx-Chex for BCP

K260041 · Streck, LLC · Mar 2026

MDx-Chex for BCN

K254166 · Streck · Mar 2026

MDx-Chex for BCY

K254167 · Streck, LLC · Mar 2026

FDA 510(k) Resources - Microbiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K263232

Maine Molecular Quality Controls, Inc.

Saco, ME · US

Joan Gordon

Regulatory profile

17 submissions 16 cleared

94% clearance rate · Active in Microbiology

View all devices by Maine Molecular Quality Controls, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 30, 2026. Record added to 510k Database: November 2026. Enriched with classification and manufacturer data: November 2026.

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