DEN190016 is an FDA 510(k) submission for the cobas vivoDx MRSA. This device is classified as a Culture-based Short-term Incubation Antimicrobial Resistance Assay (Class II - Special Controls, product code QIV).
Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on December 5, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1655. A System For Detection Of Microorganisms And Antimicrobial Resistance Using Reporter Expression Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Live Microorganisms And The Detection Of Associated Antimicrobial Drug Susceptibility Or Resistance In Specimens From Patients At Risk Of Colonization Or Suspected Of Infection..
| 510(k) Number | DEN190016 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 19, 2019 |
| Decision Date | December 05, 2019 |
| Days to Decision | 261 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | QIV — Culture-based Short-term Incubation Antimicrobial Resistance Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1655 |
| Definition | A System For Detection Of Microorganisms And Antimicrobial Resistance Using Reporter Expression Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Live Microorganisms And The Detection Of Associated Antimicrobial Drug Susceptibility Or Resistance In Specimens From Patients At Risk Of Colonization Or Suspected Of Infection. |