LIAISON PLEX Gastrointestinal Flex Assay

Q: What is the product code of K253722?

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) K253722 · Luminex Corporation

Substantially Equivalent

510(k) numberK253722

Submission

Device name: LIAISON PLEX Gastrointestinal Flex Assay
Applicant: Luminex Corporation
Northbrook, IL, US
Received: November 24, 2025
Decision date: May 19, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
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
K243813	QIAstat-Dx GI Panel 2 Mini B&VPCH · Special	QIAGEN GmbH	01/08/2025SE
K242367	BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional	Biofire Diagnostics, LLC	11/07/2024SE

More from Biofire Diagnostics, LLC

510(k)	Device	Decision
K243490	LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional	06/06/2025SE
K243013	LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional	04/18/2025SE
K240627	LIAISON PLEX Yeast Blood Culture AssayPEO · Traditional	06/04/2024SE
K233410	LIAISON PLEX Respiratory Flex AssayQOF · Traditional	03/01/2024SE
K191742	ARIES MRSA AssayNQX · Traditional	09/25/2019SE
K172402	ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional	10/30/2017SE
K171441	ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional	07/21/2017SE
K163626	ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ · Traditional	05/02/2017SE
K162772	ARIES GBS AssayNJR · Traditional	12/23/2016SE
K161220	ARIES® Flu A/B & RSV AssayOCC · Traditional	08/02/2016SE

Questions and answers

When was LIAISON PLEX Gastrointestinal Flex Assay cleared by the FDA?

LIAISON PLEX Gastrointestinal Flex Assay (K253722) received a 510(k) decision of Substantially Equivalent on May 19, 2026, 176 days after the submission was received.

What is the product code of K253722?

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.