Cleared Traditional

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

K233611 · Maine Molecular Quality Controls, Inc. · Microbiology

Mar 2024

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K233611 is an FDA 510(k) clearance for the SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738), 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 March 26, 2024, 134 days after receiving the submission on November 13, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K233611 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2023
Decision Date	March 26, 2024
Days to Decision	134 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.