Cleared Traditional

K092454 - VITEK 2 YEAST VORICONAZOLE

K092454 is the FDA 510(k) clearance for VITEK 2 YEAST VORICONAZOLE by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code NGZ) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K092454 · bioMerieux, Inc. · Microbiology device
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May 2010
Decision
284d
Days
Class 2
Risk

K092454 is an FDA 510(k) clearance for the VITEK 2 YEAST VORICONAZOLE. 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 May 21, 2010 after a review of 284 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 K092454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2009
Decision Date May 21, 2010
Days to Decision 284 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
182d slower than avg
Panel avg: 102d · This submission: 284d
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 18
Devices cleared under the same product code (NGZ) and FDA review panel - the closest regulatory comparables to K092454.
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
VITEK 2 YEAST CASPOFUNGIN
K101566 · bioMerieux, Inc. · Sep 2010
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · Trek Diagnostic Systems, Inc. · Jun 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K081063 · Trek Diagnostic Systems, Inc. · Mar 2009
VITEK 2 AST-YS FLUCONAZOLE
K061945 · bioMerieux, Inc. · Sep 2006