FDA.reportPublic FDA data

510(k) K191160

Device
XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)
Applicant
Luminex Molecular Diagnostics, Inc.
510(k) number
K191160
Product code
PCH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-04
Date received
2019-05-01
Regulation
866.3990
Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Tina Ip
Address
439 University Ave. Toronto CA M5G 1Y8 M5G 1Y8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PCH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation2026-05-19
K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH2026-03-09
K251721Xpert GI PanelCepheid2026-01-16
K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH2025-10-22
K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.2025-09-25
K251868Panther Fusion GI Bacterial AssayHologic2025-09-25
K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH2025-02-28
K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC2025-01-16
K242877BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.2025-01-10
K243813QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH2025-01-08
K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC2024-11-07
K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH2024-05-31
K232672EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited2024-05-29
K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC2023-03-16
K220607BD MAX Enteric Viral PanelBecton, Dickinson and Company2022-09-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Decision Summary