Luminex Corporation: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Luminex Corporation” (first 2008, latest 2026), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 131 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 245 |
| 2014 | 1 | 77 |
| 2015 | 2 | 85 |
| 2016 | 4 | 64 |
| 2017 | 3 | 82 |
| 2018 | 0 | — |
| 2019 | 1 | 86 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 118 |
| 2025 | 2 | 204 |
| 2026 | 1 | 176 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Luminex Corporation took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | 3 | 3 |
| OOI | Real Time Nucleic Acid Amplification System | 3 | 3 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | 1 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 1 | 1 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 1 | 1 |
| OZZ | Bordetella Pertussis Dna Assay System | 1 | 1 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 1 | 1 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 1 | 1 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 1 | 1 |
Plus 4 more product codes.
Review panels
- Microbiology (12)
- Clinical Chemistry (6)
Most recent Luminex Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | PCH | 2026-05-19 | 176 |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | PAM | 2025-06-06 | 206 |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | PEN | 2025-04-18 | 203 |
| K240627 | LIAISON PLEX Yeast Blood Culture Assay | PEO | 2024-06-04 | 90 |
| K233410 | LIAISON PLEX Respiratory Flex Assay | QOF | 2024-03-01 | 147 |
| K191742 | ARIES MRSA Assay | NQX | 2019-09-25 | 86 |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | PGX | 2017-10-30 | 82 |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit | OZN | 2017-07-21 | 66 |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | OZZ | 2017-05-02 | 131 |
| K162772 | ARIES GBS Assay | NJR | 2016-12-23 | 81 |
8 earlier clearances. See the full list in Caduvo.
Recalls
40 product recalls in 25 recall events; 12 initiated in the last five years. Most recent: 2025-04-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Luminex Corporation is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03037957: A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients (Completed, started 2017-01-09)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Luminex Molecular Diagnostics, Inc. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Luminex Corporation?
FDA lists 18 510(k) clearances under the applicant name “Luminex Corporation” (first 2008, latest 2026), across 14 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Luminex Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Luminex Corporation is 86 days. Since 2017: 131 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Luminex Corporation?
The most frequent FDA product codes under this applicant name are NSU (Instrumentation For Clinical Multiplex Test Systems, 3); OOI (Real Time Nucleic Acid Amplification System, 3); NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test, 1).
Next steps
- See all 18 Luminex Corporation clearances with predicates and recalls
- Run predicate analysis for product code NSU, Luminex Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.