510(k) DEN190016
DEN190016 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas vivoDx MRSA". The FDA issued a decision of De Novo granted on Dec 5, 2019. The device falls under product code QIV (Culture-Based Short-Term Incubation Antimicrobial Resistance Assay), a Class II device regulated under 21 CFR 866.1655. Roche Molecular Systems, Inc. has 54 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Dec 5, 2019
- Date Received
- Mar 19, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
- Device Class
- Class II
- Regulation Number
- 866.1655
- Review Panel
- MI
- Submission Type
- 510(k)
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.