Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Luminex Molecular Diagnostics, Inc. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
269 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. | 2024-10-02 | 29 | 0 |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Luminex Molecular Diagnostics, Inc. | 2024-03-11 | 269 | 0 |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen | Luminex Molecular Diagnostics, Inc. | 2019-12-11 | 26 | 1 |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | 2019-11-12 | 195 | 0 |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analys | Luminex Molecular Diagnostics, Inc. | 2019-11-04 | 187 | 0 |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analys | Luminex Molecular Diagnostics, Inc. | 2018-11-30 | 29 | 0 |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analys | Luminex Molecular Diagnostics, Inc. | 2018-11-30 | 29 | 0 |
| K170492 | xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | 2017-08-11 | 175 | 0 |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics, Inc. | 2016-12-15 | 17 | 0 |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software | Luminex Molecular Diagnostics, Inc. | 2016-12-15 | 17 | 0 |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen | Luminex Molecular Diagnostics, Inc. | 2015-12-17 | 115 | 1 |
| K140647 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS | Luminex Molecular Diagnostics, Inc. | 2014-10-24 | 225 | 0 |
| K140377 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSI | Luminex Molecular Diagnostics, Inc. | 2014-09-16 | 214 | 0 |
| K131565 | XTAG CYP2C19 KIT V3 | Luminex Molecular Diagnostics, Inc. | 2013-09-11 | 104 | 0 |
| K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 | 116 | 0 |
| K121894 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS | Luminex Molecular Diagnostics, Inc. | 2013-03-21 | 265 | 0 |
| DEN130003 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSI | Luminex Molecular Diagnostics, Inc. | 2013-01-14 | 3 | 0 |
| K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS | Luminex Molecular Diagnostics, Inc. | 2012-02-17 | 144 | 0 |
| K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (T | Luminex Molecular Diagnostics, Inc. | 2011-09-01 | 31 | 0 |
| K103776 | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWA | Luminex Molecular Diagnostics, Inc. | 2011-07-01 | 186 | 0 |
| K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP | Luminex Molecular Diagnostics, Inc. | 2010-08-26 | 296 | 1 |
| K083845 | XTAG CF60 KIT V2 | Luminex Molecular Diagnostics, Inc. | 2009-12-11 | 352 | 0 |
| K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027 | Luminex Molecular Diagnostics, Inc. | 2009-09-01 | 251 | 0 |
| K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I0 | Luminex Molecular Diagnostics, Inc. | 2009-06-25 | 16 | 0 |
| K081483 | XTAG RESPIRATORY VIRAL PANEL | Luminex Molecular Diagnostics, Inc. | 2008-06-25 | 28 | 0 |
| DEN070013 | ID-TAG RESPIRATORY VIRAL PANEL | Luminex Molecular Diagnostics, Inc. | 2008-01-03 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda