DEN180030 is an FDA 510(k) submission for the QMS Plazomicin Immunoassay. This device is classified as a Plazomicin Test System, Immunoassay (Class II - Special Controls, product code QDR).
Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Not Cleared (DENG) decision on November 19, 2018.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3460. A Plazomicin Test System Is A Device Intended To Measure Plazomicin In Human Specimens. Measurements Obtained By This Device Are Used In Monitoring Levels Of Plazomicin To Ensure Appropriate Therapy In Patients With Complicated Urinary Tract Infection..
| 510(k) Number | DEN180030 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 25, 2018 |
| Decision Date | November 19, 2018 |
| Days to Decision | 147 days |
| Submission Type | Direct |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | QDR — Plazomicin Test System, Immunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3460 |
| Definition | A Plazomicin Test System Is A Device Intended To Measure Plazomicin In Human Specimens. Measurements Obtained By This Device Are Used In Monitoring Levels Of Plazomicin To Ensure Appropriate Therapy In Patients With Complicated Urinary Tract Infection. |