Question 1

What types of medical devices does Luminex Molecular Diagnostics, Inc. manufacture?

Accepted Answer

Luminex Molecular Diagnostics, Inc. specializes in in vitro diagnostic (IVD) kits that perform multiplex nucleic acid testing and genetic polymorphism analysis. Their devices include assays for detecting cystic fibrosis mutations, respiratory viruses (such as influenza, RSV, and others), gastrointestinal pathogens, and variations in cytochrome P450 (CYP450) genes. These products are designed for clinical use to identify genetic markers and infectious agents through advanced nucleic acid techniques.

Question 2

Where is Luminex Molecular Diagnostics, Inc. based?

Accepted Answer

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and operations are conducted within the U.S., aligning with FDA requirements for medical device manufacturers.

Question 3

Which regulatory registries list Luminex Molecular Diagnostics’ devices?

Accepted Answer

Luminex’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure compliance with U.S. medical device authorization processes, as Class II devices require pre-market clearance or de novo classification before commercial distribution.

Question 4

How are Luminex Molecular Diagnostics’ devices classified by regulatory authorities?

Accepted Answer

All of Luminex’s listed devices fall under FDA Class II classification. This classification means they are considered moderate-risk medical devices that require pre-market notification (510(k)) or de novo clearance to demonstrate substantial equivalence to a predicate device or to establish safety and effectiveness. The FDA’s UDI system further tracks these devices post-authorization.

Question 5

Do Luminex’s devices include software for data analysis?

Accepted Answer

Yes, some of Luminex’s IVD kits are accompanied by proprietary software solutions, such as the TDAS (xTAG Data Analysis Software), to assist with data interpretation and reporting. These software tools are integrated into the diagnostic workflow to enhance accuracy and efficiency in clinical settings, particularly for multiplex assays.

Device	Model / Reference	Registries	Class	Status
xTAG® CYP2D6 Kit v3	I030E0443	FDA UDI	Class II	Unknown
xTAG® Cystic Fibrosis Mutation Detection Kit	I006C0068	FDA UDI	Class II	Unknown
xTAG® CYP2D6 Kit v3	I030B0373	FDA UDI	Class II	Unknown
NxTAG® Respiratory Pathogen Panel	I051C0447	FDA UDI	Class II	Active
xTAG® Gastrointestinal Pathogen Panel (GPP)	I032C0316	FDA UDI	Class II	Active
xTAG® RVP (Respiratory Viral Panel)	I019C0111	FDA UDI	Class I	Unknown
xTAG® Cystic Fibrosis (CFTR) 39 kit v2	I027C0231	FDA UDI	Class II	Active
xTAG® RVP FAST (Respiratory Viral Panel Fast)	I025C0197	FDA UDI	Class II	Unknown
xTAG® Cystic Fibrosis (CFTR) 60 kit v2	I024C0181	FDA UDI	Class II	Active
xTAG® CYP2C19 Kit v3	I046B0427	FDA UDI	Class II	Active
NxTAG® Respiratory Pathogen Panel v2	I055C0465	FDA UDI	Class II	Active
Xtag Cyp2d6 Kit V3, Model I030c0300 (96 Tests/Kit), Tdas Cyp2d6 Software (2030-0254)	K093420	FDA 510(k)	Class II	Active
Xtag Cyp2d6 Kit V3 (including Tdas Cyp2d6 Software)	K130189	FDA 510(k)	Class II	Active
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)	K231758	FDA 510(k)	Class II	Active
Xtag Respiratory Viral Panel, Xtag Data Analysis Software (tdas Rvp-1)	K112199	FDA 510(k)	Class II	Active
Xtag Cystic Fibrosis 39 Kit V2, (cftr 39 Kit V2), Model I027c0231, I027d0266, I027e0267	K083846	FDA 510(k)	Class II	Active
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR	K163336	FDA 510(k)	Class II	Active
Tag Respiratory Viral Panel Tag Data Analysis Software (tdas Rvp-I)	K112781	FDA 510(k)	Class II	Active
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	K183023	FDA 510(k)	Class II	Active
Xtag Respiratory Viral Panel, Models I019a0110, I019c011, I019d0112, I019e0113, S019-0116	K091667	FDA 510(k)	Class II	Active
Xtag Gastrointestinal Pathogen Panel (gpp) Xtag Data Analysis Software For Gpp (tdas)	DEN130003	FDA 510(k)	Class II	Active
Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software For Rvp Fast	K103776	FDA 510(k)	Class II	Active
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	K191160	FDA 510(k)	Class II	Active
xTAG Cystic Fibrosis 39 Kit v2	K163347	FDA 510(k)	Class II	Active
Xtag Cyp2c19 Kit V3	K131565	FDA 510(k)	Class II	Active
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)	K183030	FDA 510(k)	Class II	Active
Id-Tag Respiratory Viral Panel	DEN070013	FDA 510(k)	Class II	Active
Xtag Cf60 Kit V2	K083845	FDA 510(k)	Class II	Active
xTAG CYP2D6 Kit v3	K170492	FDA 510(k)	Class II	Active
Xtag Respiratory Viral Panel	K081483	FDA 510(k)	Class II	Active
xTAG Gastrointestinal Pathogen Panel (GPP)	K191161	FDA 510(k)	Class II	Active
NxTAG® Respiratory Pathogen Panel	K242613	FDA 510(k)	Class II	Active
Xtag Gastrointestinal Pathogen Panel (gpp)/Xtag Data Analysis Software For Gpp (tdas Gpp)	K140377	FDA 510(k)	Class II	Active
Xtag Gastrointestinal Pathogen Panel(gpp)/Xtag Data Analysis Software For Gpp(tdas Gpp)	K140647	FDA 510(k)	Class II	Active
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	K193167	FDA 510(k)	Class II	Active
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	K152386	FDA 510(k)	Class II	Active
Xtag Gastrointestinal Pathogen Panel(gpp) Xtag Data Analysis Software For Gpp (tdas Gpp) Luminex Magpix	K121894	FDA 510(k)	Class II	Active

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