# DEN190016: cobas vivoDx MRSA

- Pathway: De Novo (Direct)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Dec 5, 2019 after 261 days
- Product code: QIV (Culture-Based Short-Term Incubation Antimicrobial Resistance Assay)
- Device class: 2
- Regulation: 21 CFR 866.1655
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The cobas vivoDx MRSA test performed on the cobas vivoDx System is an automated qualitative in vitro diagnostic test for the direct detection of live methicillin-resistant Staphylococcus aureus (MRSA) cells in nasal swab samples from patients who are at risk for nasal colonization by MRSA. The test utilizes selective agents and bioparticles (Smarticles technology) to introduce a luciferase gene into targeted bacteria to create an amplified luminescent signal in only viable (live) MRSA cells. The cobas vivoDx MRSA test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections, nor to guide, or monitor treatment. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. The cobas vivoDx MRSA Collection and Transport Kit is used to collect, transport and store human nasal swab specimens for use with the cobas vivoDx MRSA test.

Source page: https://510kreport.com/device/DEN190016
Methodology: https://510kreport.com/methodology