Cleared Traditional

K151923 - VITEK 2 AST-Yeast Micafungin (0.06-8 mc...

K151923 is the FDA 510(k) clearance for VITEK 2 AST-Yeast Micafungin (0.06-8 mc... by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code NGZ) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K151923 · bioMerieux, Inc. · Microbiology device
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Mar 2016
Decision
256d
Days
Class 2
Risk

K151923 is an FDA 510(k) clearance for the VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL). Classified as Susceptibility Test Plate, Antifungal (product code NGZ), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 25, 2016 after a review of 256 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 K151923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2015
Decision Date March 25, 2016
Days to Decision 256 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
154d slower than avg
Panel avg: 102d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGZ Susceptibility Test Plate, Antifungal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.
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 Peers - NGZ Susceptibility Test Plate, Antifungal

All 14
Devices cleared under the same product code (NGZ) and FDA review panel - the closest regulatory comparables to K151923.
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
K221899 · Thermo Fisher Scientific · Jan 2023
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
K211539 · Thermo Fisher Scientific · Dec 2021
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
K181368 · bioMerieux, Inc. · Jun 2018
VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
K151817 · bioMerieux, Inc. · Feb 2016
VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
K133952 · bioMerieux, Inc. · Aug 2014
VITEK 2 AST - YEAST FLUCONAZOLE
K133817 · bioMerieux, Inc. · Aug 2014