Cleared Traditional

Unyvero LRT BAL Application (K191967) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191967 · Curetis GmbH · Microbiology device
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Dec 2019
Decision
150d
Days
Class 2
Risk

K191967 is an FDA 510(k) clearance for the Unyvero LRT BAL 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 Cleared decision on December 20, 2019 after a review of 150 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Curetis GmbH devices

Submission Details

510(k) Number K191967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2019
Decision Date December 20, 2019
Days to Decision 150 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 102d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

Radcliffe Consulting, Inc.
Gail Radcliffe

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.