# Luminex Molecular Diagnostics, Inc.

- Location (FDA's records): Toronto, CA
- FDA decisions: 26 (2008–2024): 24 510(k) clearances and 2 De Novo grants
- Product codes: OCC (9), PCH (8), NTI (4), NUA (4), QOF (1)
- 510(k) review time since 2016: median 108 days, against 126 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 17 (11 its own); citations of its devices by later devices: 44 (11 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tm Bioscience Corporation: 4 (https://510kreport.com/company/tm-bioscience)
- Roche Molecular Systems, Inc.: 1 (https://510kreport.com/company/roche-molecular-systems)
- Biofire Diagnostics, LLC: 1 (https://510kreport.com/company/biofire-diagnostics)

## Firms that cite its devices most
- Gen-Probe Prodesse, Inc.: 11 (https://510kreport.com/company/gen-probe-prodesse)
- Idaho Technology, Inc.: 6 (https://510kreport.com/company/idaho-technology)
- Prodesse, Inc.: 4 (https://510kreport.com/company/prodesse)
- Focus Diagnostics, Inc.: 3 (https://510kreport.com/company/focus-diagnostics)
- Nanospere,Inc.: 2 (https://510kreport.com/company/nanospere)
- Illumina, Inc.: 2 (https://510kreport.com/company/illumina)
- Applied BioCode, Inc.: 1 (https://510kreport.com/company/applied-biocode)
- Biofire Diagnostics, LLC: 1 (https://510kreport.com/company/biofire-diagnostics)

## Its most-cited devices
- DEN070013: ID-Tag Respiratory Viral Panel (2008), cited by 12
- K081483: Xtag Respiratory Viral Panel (2008), cited by 11
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 (2009), cited by 9
- DEN130003: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas) (2013), cited by 5
- K121894: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas GPP) Luminex Magpix (2013), cited by 4
- K083845: Xtag CF60 Kit V2 (2009), cited by 2

## Recent decisions
- K242613: NxTAG® Respiratory Pathogen Panel (Oct 2, 2024)
- K231758: NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) (Mar 11, 2024)
- K193167: NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (Dec 11, 2019)
- K191161: xTAG Gastrointestinal Pathogen Panel (GPP) (Nov 12, 2019)
- K191160: xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (Nov 4, 2019)
- K183030: xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (Nov 30, 2018)
- K183023: xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (Nov 30, 2018)
- K170492: xTAG CYP2D6 Kit v3 (Aug 11, 2017)

Source page: https://510kreport.com/company/luminex-molecular-diagnostics