Cleared Special

SPOTFIRE? RSP Pos & Neg Controls, SPOTFIRE? RSP Positive Control, SPOTFIRE? RSP Negative Control

K230868 · Maine Molecular Quality Controls, Inc. · Microbiology

Apr 2023

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K230868 is an FDA 510(k) clearance for the SPOTFIRE? RSP Pos & Neg Controls, 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 April 13, 2023, 15 days after receiving the submission on March 29, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K230868 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2023
Decision Date	April 13, 2023
Days to Decision	15 days
Submission Type	Special
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.