QIAstat-Dx GI Panel 2 Mini B&V

Q: What is the product code of K243813?

The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.

FDA 510(k) K243813 · QIAGEN GmbH

Substantially Equivalent

510(k) numberK243813

Submission

Device name: QIAstat-Dx GI Panel 2 Mini B&V
Applicant: QIAGEN GmbH
Hilden, DE
Received: December 11, 2024
Decision date: January 8, 2025
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3990
Specialty: Microbiology

A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal…

Other 510(k)s with product code PCH

510(k)	Device	Applicant	Decision
K253722	LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional	Luminex Corporation	05/19/2026SE
K254032	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional	QIAGEN GmbH	03/09/2026SE
K251721	Xpert GI PanelPCH · Traditional	Cepheid	01/16/2026SE
K252329	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional	QIAGEN GmbH	10/22/2025SE
K251993	Panther Fusion GI Expanded Bacterial AssayPCH · Traditional	Hologic, Inc.	09/25/2025SE
K251868	Panther Fusion GI Bacterial AssayPCH · Traditional	Hologic	09/25/2025SE
K250324	QIAstat-Dx GI Panel 2 Mini BPCH · Special	QIAGEN GmbH	02/28/2025SE
K243885	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special	Biofire Diagnostics, LLC	01/16/2025SE
K242877	BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional	Applied BioCode, Inc.	01/10/2025SE
K242367	BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional	Biofire Diagnostics, LLC	11/07/2024SE

More from Biofire Diagnostics, LLC

510(k)	Device	Decision
K254194	QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional	08/06/2026SE
K254032	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional	03/09/2026SE
K252329	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional	10/22/2025SE
K250080	QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional	08/27/2025SE
K250324	QIAstat-Dx GI Panel 2 Mini BPCH · Special	02/28/2025SE
K242256	QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLO · Traditional	10/29/2024SE
K242353	QIAstat-Dx Respiratory Panel MiniQOF · Special	10/25/2024SE
K220062	QIAstat-Dx Gastrointestinal Panel 2PCH · Traditional	05/31/2024SE
K233100	QIAstat-Dx® Respiratory Panel PlusQOF · Traditional	05/10/2024SE
K183597	QIAstat-Dx Respiratory PanelOCC · Traditional	05/18/2019SE

Questions and answers

When was QIAstat-Dx GI Panel 2 Mini B&V cleared by the FDA?

QIAstat-Dx GI Panel 2 Mini B&V (K243813) received a 510(k) decision of Substantially Equivalent on January 8, 2025, 28 days after the submission was received.

What is the product code of K243813?

The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.