De Novo · Granted

Granted

cobas vivoDx MRSA

DEN190016De NovoGranted Dec 5, 2019261-day reviewClass II21 CFR 866.1655

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Molecular Systems, Inc. · QIV Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

Granted on Dec 5, 2019 as a new device type through De Novo after a 261-day review.

Decided: Dec 5, 2019
Review: 261 days
Class: Class II
Product code: QIV
Recalls: None

De Novo grants create a new device type without a predicate, so this family tree starts here.

FIG. 1 — Lineage of DEN190016Source: FDA De Novo database · How lineage is built

Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QIV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All QIV devices

QIV Culture-Based Short-Term Incubation Antimicrobial Resistance Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · QIV

1in 2019

2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QIV

Too few QIV 510(k)s in any year since 2007 to give a median.

Recalls per year · QIV

No recall names QIV since 2007.

Adverse event reports per year · QIV

No MAUDE report names QIV since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (150 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/DEN190016 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN190016: cobas vivoDx MRSA.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190016

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026