Cleared Traditional

BioFire JI Control Panel M420

K203680 · Maine Molecular Quality Controls, Inc. · Microbiology

Jul 2022

Decision

582d

Days

Class 2

Risk

About This 510(k) Submission

K203680 is an FDA 510(k) clearance for the BioFire JI Control Panel M420, 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 July 22, 2022, 582 days after receiving the submission on December 17, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3920.

Submission Details

510(k) Number	K203680 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2020
Decision Date	July 22, 2022
Days to Decision	582 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.