PGDx Elio™ Server
PGDx elio server is a dedicated computer platform for analysis and reporting software used with the elio tissue complete CDx assay family. The server processes sequencing data in the elio…
PGDx elio server is a dedicated computer platform for analysis and reporting software used with the elio tissue complete CDx assay family. The server processes sequencing data in the elio workflow and produces assay reports.
The filed item is a reconditioned 128C server configuration. A later elio CDx manual documents an example workflow in which the software analyzes compatible sequencing output and saves reports; those workflow details are not assigned to every server configuration.
Listed Item
PGDx elio™ server (reconditioned 128C)
Analysis and Reporting
In the documented assay workflow, the server software identifies genomic alterations from sequencing output and generates reports. The server is the computing and reporting component, separate from the sequencing instrument.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Geneseeq Medical Device AND Diagnostic Inc. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Personal Genome Diagnostics Inc., United States |
|---|---|
| FDA product code | PZM |
| Device type | Next Generation Sequencing Based Tumor Profiling Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.6080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K192063 |
| Record published | 2020-11-17 |
| Record revised | 2024-08-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-01-30800 | In distribution | |
| B-01-10800 | In distribution | |
| B-01-40800 | In distribution | |
| B-01-20800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PGDx elio™ tissue complete | Personal Genome Diagnostics Inc. | 2 |
| Geneseeqprime NGS Tumor Profiling Assay (Ffpe) | Geneseeq Technology Inc. | 1 |
| PGDx elio™ platform | Personal Genome Diagnostics Inc. | 1 |
| Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq software | Geneseeq Technology Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192063 | 2020-04-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.