Not Cleared Direct

cobas vivoDx MRSA (DEN190016) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190016 · Roche Molecular Systems, Inc. · Microbiology device
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Dec 2019
Decision
261d
Days
Class 2
Risk

DEN190016 is an FDA 510(k) submission (not cleared) for the cobas vivoDx MRSA. Classified as Culture-based Short-term Incubation Antimicrobial Resistance Assay (product code QIV), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on December 5, 2019 after a review of 261 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1655 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 261 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 102d · This submission: 261d
Pathway characteristics

Device Classification

Product Code QIV Culture-based Short-term Incubation Antimicrobial Resistance Assay
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.