Data / Medical devices / Canada / Luminex Molecular Diagnostics, Inc.

Luminex Molecular Diagnostics, Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 18 510(k) clearances

Name: Luminex Molecular Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Luminex Molecular Diagnostics, Inc. is registered with the FDA (registration 3002777243) in TORONTO Ontario, Canada. It lists 16 device types. The FDA files 18 510(k) clearances under its listings, the newest dated October 2, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002777243
Address: 439 University Ave., TORONTO Ontario, Canada, M5G 1Y8
Owner or operator: Luminex Corporation (9032042)
Roles: Manufacturer
First device listed: April 9, 2004
Registered through: 2026
Brand names listed: Gastrointestinal Pathogen Panel (GPP), NXTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2), NxTAG® Respiratory Pathogen Panel, TAG-IT, Xtag Cystic Fibrosis 39 Kit V2, Xtag Cystic Fibrosis 60 Kit V2 and more

Devices it lists

Device	Product code	Class	Role	Source
Chlamydophila Pneumoniae Dna Assay System	OZY	2	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer	accessdata.fda.gov
Drug Metabolizing Enzyme Genotyping Systems	NTI	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	PCH	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	2	Manufacturer	accessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid Assay	OEP	2	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer	accessdata.fda.gov
Mycoplasma Pneumoniae Dna Assay System	OZX	2	Manufacturer	accessdata.fda.gov
Non-Sars Coronavirus Multiplex Nucleic Acid Assay	OTG	2	Manufacturer	accessdata.fda.gov
Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna	NXD	2	Manufacturer	accessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid Assay	OOU	2	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer	accessdata.fda.gov
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection	NUA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 2, 2024	K242613	NxTAG® Respiratory Pathogen Panel	OCC	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
March 11, 2024	K231758	NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)	QOF	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
December 11, 2019	K193167	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	OCC	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
November 12, 2019	K191161	xTAG Gastrointestinal Pathogen Panel (GPP)	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
November 4, 2019	K191160	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
November 30, 2018	K183030	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
November 30, 2018	K183023	xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
December 15, 2016	K163347	xTAG Cystic Fibrosis 39 Kit v2	NUA	Unknown	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
December 15, 2016	K163336	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR	NUA	Unknown	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
December 17, 2015	K152386	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	OCC	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
October 24, 2014	K140647	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
September 16, 2014	K140377	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
September 11, 2013	K131565	XTAG CYP2C19 KIT V3	NTI	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
March 21, 2013	K121894	XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX	PCH	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
January 14, 2013	DEN130003	XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)	PCH	Unknown	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
December 11, 2009	K083845	XTAG CF60 KIT V2	NUA	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
September 1, 2009	K083846	XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267	NUA	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov
January 3, 2008	DEN070013	ID-TAG RESPIRATORY VIRAL PANEL	OCC	Unknown	Luminex Molecular Diagnostics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 5, 2024	95377	Class II	Ongoing	NxTAG Respiratory Pathogen Panel, REF: I051C0447	Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.	accessdata.fda.gov
July 16, 2019	83472	Class II	Ongoing	xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test	The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.	accessdata.fda.gov
February 22, 2019	82745	Class II	Ongoing	xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD,	Reports have been received of lower MS2 MFI values when using the panel.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.