Cleared Special

K181368 - VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)

K181368 is an FDA 510(k) clearance for VITEK 2 AST-YS Micafungin (<=0.06 - =>8..., manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with product code NGZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K181368 · bioMerieux, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
28d
Days
Class 2
Risk

K181368 is an FDA 510(k) clearance for the VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/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 June 20, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K181368

510(k) Number K181368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2018
Decision Date June 20, 2018
Days to Decision 28 days
Submission Type Special
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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

NGZ Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (NGZ) and FDA review panel - the closest regulatory comparables to K181368.
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
K221198 · Thermo Fisher Scientific · Mar 2023
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-Yeast Micafungin (0.06-8 mcg/mL)
K151923 · bioMerieux, Inc. · Mar 2016
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
K181368 · VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
Download PDF FDA Summary bioMerieux, Inc.