Luminex Molecular Diagnostics, Inc.: FDA clearances and approvals
Luminex Molecular Diagnostics, Inc. has 24 FDA 510(k) clearances (first 2008, latest 2024), plus 2 De Novo decisions, across 5 product codes in 3 review panels. Median 510(k) review time: 130 days. Since 2017 its median was 102 days, against 138 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Luminex Molecular Diagnostics, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 144 |
| 2013 | 3 | 116 |
| 2014 | 2 | 220 |
| 2015 | 1 | 115 |
| 2016 | 2 | 17 |
| 2017 | 1 | 175 |
| 2018 | 2 | 29 |
| 2019 | 3 | 187 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 149 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Luminex Molecular Diagnostics, Inc.'s cleared 510(k)s took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 9 | 8 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 8 | 7 |
| NTI | Drug Metabolizing Enzyme Genotyping Systems | 4 | 4 |
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | 4 | 4 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 1 | 1 |
Review panels
- Microbiology (18)
- Pathology (4)
- Clinical Toxicology (4)
Most recent Luminex Molecular Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | OCC | 2024-10-02 | 29 |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | QOF | 2024-03-11 | 269 |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | OCC | 2019-12-11 | 26 |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | PCH | 2019-11-12 | 195 |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | 2019-11-04 | 187 |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | 2018-11-30 | 29 |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | 2018-11-30 | 29 |
| K170492 | xTAG CYP2D6 Kit v3 | NTI | 2017-08-11 | 175 |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | NUA | 2016-12-15 | 17 |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | NUA | 2016-12-15 | 17 |
14 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130003 | De Novo | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2013-01-14 |
| DEN070013 | De Novo | Respiratory Virus Panel Nucleic Acid Assay System | 2008-01-03 |
Recalls
4 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2024-09-05.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Luminex Molecular Diagnostics, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02862262: A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients (Completed, started 2016-07)
- NCT01787227: A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel (Completed, started 2015-01)
Frequently asked questions
How many FDA 510(k) clearances does Luminex Molecular Diagnostics, Inc. have?
Luminex Molecular Diagnostics, Inc. has 24 FDA 510(k) clearances (first 2008, latest 2024), plus 2 De Novo decisions, across 5 product codes in 3 review panels.
How long does FDA take to clear Luminex Molecular Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Luminex Molecular Diagnostics, Inc.'s cleared 510(k)s is 130 days. Since 2017: 102 days, versus 138 days for all cleared 510(k)s in the same product codes.
What devices does Luminex Molecular Diagnostics, Inc. make?
Its most frequent FDA product codes are OCC (Respiratory Virus Panel Nucleic Acid Assay System, 9); PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, 8); NTI (Drug Metabolizing Enzyme Genotyping Systems, 4).
Has Luminex Molecular Diagnostics, Inc. had device recalls?
openFDA lists 4 product recalls in 3 recall events by a recalling firm whose name matches Luminex Molecular Diagnostics, Inc; the most recent began 2024-09-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 24 Luminex Molecular Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCC, Luminex Molecular Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.