Cleared Traditional

K133817 - VITEK 2 AST - YEAST FLUCONAZOLE

K133817 is the FDA 510(k) clearance for VITEK 2 AST - YEAST FLUCONAZOLE by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code NGZ) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K133817 · bioMerieux, Inc. · Microbiology device
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Aug 2014
Decision
232d
Days
Class 2
Risk

K133817 is an FDA 510(k) clearance for the VITEK 2 AST - YEAST FLUCONAZOLE. Classified as Susceptibility Test Plate, Antifungal (product code NGZ), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on August 5, 2014 after a review of 232 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 K133817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2013
Decision Date August 05, 2014
Days to Decision 232 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
130d slower than avg
Panel avg: 102d · This submission: 232d
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 K133817.
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
VITEK 2 YEAST CASPOFUNGIN
K101566 · bioMerieux, Inc. · Sep 2010
VITEK 2 YEAST VORICONAZOLE
K092454 · bioMerieux, Inc. · May 2010
VITEK 2 AST-YS FLUCONAZOLE
K061945 · bioMerieux, Inc. · Sep 2006