Genmark Diagnostics, Incorporated: FDA clearances and approvals
Genmark Diagnostics, Incorporated has 7 FDA 510(k) clearances (first 2016, latest 2022), across 6 product codes in 3 review panels. Median 510(k) review time: 178 days. Since 2017 its median was 174 days, against 105 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 255 |
| 2017 | 2 | 168 |
| 2018 | 2 | 132 |
| 2019 | 1 | 200 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 209 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Genmark Diagnostics, Incorporated's cleared 510(k)s took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 2 | 2 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 1 | 1 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 1 | 1 |
| ODW | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | 1 | 1 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 1 | 1 |
| PEO | Fungal Organisms, Nucleic Acid-Based Assay | 1 | 1 |
Review panels
Most recent Genmark Diagnostics, Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | PEN | 2022-04-27 | 209 |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | PEN | 2019-04-12 | 200 |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | PEO | 2018-12-21 | 85 |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | PAM | 2018-12-20 | 178 |
| K163652 | ePlex Instrument | NSU | 2017-06-09 | 168 |
| K163636 | ePlex Respiratory Pathogen Panel | OCC | 2017-06-09 | 169 |
| K152612 | eSensor Warfarin Sensitivity Saliva Test | ODW | 2016-05-26 | 255 |
Recalls
openFDA lists no recalls under a recalling firm named Genmark Diagnostics, Incorporated.
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.
Frequently asked questions
How many FDA 510(k) clearances does Genmark Diagnostics, Incorporated have?
Genmark Diagnostics, Incorporated has 7 FDA 510(k) clearances (first 2016, latest 2022), across 6 product codes in 3 review panels.
How long does FDA take to clear Genmark Diagnostics, Incorporated's 510(k)s?
The median time from FDA receipt to decision across Genmark Diagnostics, Incorporated's cleared 510(k)s is 178 days. Since 2017: 174 days, versus 105 days for all cleared 510(k)s in the same product codes.
What devices does Genmark Diagnostics, Incorporated make?
Its most frequent FDA product codes are PEN (Gram-Negative Bacteria And Associated Resistance Markers, 2); NSU (Instrumentation For Clinical Multiplex Test Systems, 1); OCC (Respiratory Virus Panel Nucleic Acid Assay System, 1).
Has Genmark Diagnostics, Incorporated had device recalls?
openFDA lists no recalls under a recalling firm name matching Genmark Diagnostics, Incorporated. Related entities may recall under other names.
Next steps
- See all 7 Genmark Diagnostics, Incorporated clearances with predicates and recalls
- Run predicate analysis for product code PEN, Genmark Diagnostics, Incorporated'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.