Cleared Traditional

K161816 - BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (FDA 510(k) Clearance)

Class I Microbiology device.

K161816 · bioMerieux, Inc. · Microbiology device
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Mar 2017
Decision
270d
Days
Class 1
Risk

K161816 is an FDA 510(k) clearance for the BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 28, 2017 after a review of 270 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K161816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2016
Decision Date March 28, 2017
Days to Decision 270 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 102d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDB System, Blood Culturing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.