Not Cleared Direct

Curetis Unyvero LRT Application (DEN170047) - FDA 510(k) Clearance

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

DEN170047 · Curetis GmbH · Microbiology device
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Apr 2018
Decision
204d
Days
Class 2
Risk

DEN170047 is an FDA 510(k) submission (not cleared) for the Curetis Unyvero LRT Application. Classified as Lower Respiratory Microbial Nucleic Acid Detection System (product code QBH), Class II - Special Controls.

Submitted by Curetis GmbH (Holzgerlingen, DE). The FDA issued a Not Cleared (DENG) decision on April 3, 2018 after a review of 204 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3985 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all Curetis GmbH devices

Submission Details

510(k) Number DEN170047 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 11, 2017
Decision Date April 03, 2018
Days to Decision 204 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 102d · This submission: 204d
Pathway characteristics

Device Classification

Product Code QBH Lower Respiratory Microbial Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3985
Definition Device To Detect And Identify Microorganisms And Associated Resistance Marker Nucleic Acids Directly In Respiratory Specimens.
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.