Cleared Traditional

K161816 - BacT/ALERT VIRTUO Microbial Detection S...

K161816 is an FDA 510(k) clearance for BacT/ALERT VIRTUO Microbial Detection S..., manufactured by bioMerieux, Inc.. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 270-day FDA review.

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

FDA 510(k) Submission Details - K161816

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 102d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

MDB Device Classification - Class 1, General Controls

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.

Regulatory Peers - MDB System, Blood Culturing

All 56
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