FilmArray Global Fever Panel External Control Kit

Q: What is the product code of K202382?

The FDA product code is PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3920.

FDA 510(k) K202382 · Biofire Defense, LLC

Substantially Equivalent

510(k) numberK202382

Submission

Device name: FilmArray Global Fever Panel External Control Kit
Applicant: Biofire Defense, LLC
Salt Lake City, UT, US
Received: August 20, 2020
Decision date: November 20, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3920
Specialty: Microbiology

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

Other 510(k)s with product code PMN

510(k)	Device	Applicant	Decision
K261475	BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional	Biofire Defense, LLC	07/17/2026SE
K260577	FilmArray TF Control Panel M527PMN · Traditional	Maine Molecular Quality Controls, Inc.	05/19/2026SE
K260041	MDx-Chex for BCPPMN · Traditional	Streck, LLC	03/27/2026SE
K254166	MDx-Chex for BCNPMN · Traditional	Streck	03/23/2026SE
K254167	MDx-Chex for BCYPMN · Traditional	Streck, LLC	03/17/2026SE
K251526	FilmArray GI Control Panel M238PMN · Traditional	Maine Molecular Quality Controls, Inc.	08/14/2025SE
K241289	SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlPMN · Special	Maine Molecular Quality Controls, Inc.	05/30/2024SE
K233611	SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…PMN · Traditional	Maine Molecular Quality Controls, Inc.	03/26/2024SE
K231223	MDx-Chex for BC-GNPMN · Traditional	Streck	07/27/2023SE
K231221	MDx-Chex for BC-GPPMN · Traditional	Streck	07/27/2023SE

More from Streck

510(k)	Device	Decision
K261475	BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional	07/17/2026SE
K243822	BioFire Warrior Panel; BioFire Warrior Panel Control KitPRD · Traditional	03/12/2025SE
K213362	BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…QVR · Traditional	03/22/2023SE
K220870	BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelQMV · Traditional	10/20/2022SE
K221460	BioFire COVID-19 Test 2QQX · Special	07/25/2022SE
K211079	BioFire COVID-19 Test 2QQX · Traditional	11/01/2021SE
K170883	FilmArray NGDS Warrior PanelPRD · Traditional	06/22/2017SE

Questions and answers

When was FilmArray Global Fever Panel External Control Kit cleared by the FDA?

FilmArray Global Fever Panel External Control Kit (K202382) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 92 days after the submission was received.

What is the product code of K202382?

The FDA product code is PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3920.