Cleared Traditional

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

K221253 · Maine Molecular Quality Controls, Inc. · Microbiology

Feb 2023

Decision

277d

Days

Class 2

Risk

About This 510(k) Submission

K221253 is an FDA 510(k) clearance for the SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control, 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 February 3, 2023, 277 days after receiving the submission on May 2, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K221253 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2022
Decision Date	February 03, 2023
Days to Decision	277 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.