Cleared Traditional

K262573 - SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control

K262573 is an FDA 510(k) clearance for SPOTFIRE VG Control Panel M534, 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 86-day FDA review.

K262573 · 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
86d
Days
Class 2
Risk

K262573 is an FDA 510(k) clearance for the SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control. 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 21, 2026 after a review of 86 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 - K262573

510(k) Number K262573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2026
Decision Date October 21, 2026
Days to Decision 86 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
16d faster than avg
Panel avg: 102d · This submission: 86d
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 K262573.
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K262573 · SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control
Download PDF FDA Summary Maine Molecular Quali…