Cleared Traditional

ETEST VORICONAZOLE 0.002-32 UG/ML (K082534) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082534 · Ab Biomerieux · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
426d
Days
Class 2
Risk

K082534 is an FDA 510(k) clearance for the ETEST VORICONAZOLE 0.002-32 UG/ML. Classified as Susceptibility Test Plate, Antifungal (product code NGZ), Class II - Special Controls.

Submitted by Ab Biomerieux (Solna, SE). The FDA issued a Cleared decision on November 2, 2009 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Ab Biomerieux devices

Submission Details

510(k) Number K082534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date November 02, 2009
Days to Decision 426 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
324d slower than avg
Panel avg: 102d · This submission: 426d
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 20
Devices cleared under the same product code (NGZ) and FDA review panel - the closest regulatory comparables to K082534.
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
K243738 · Thermo Fisher Scientific · Feb 2025
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
K232967 · bioMerieux, Inc. · Jun 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
K232963 · bioMerieux, Inc. · Jun 2024
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
K231433 · Thermo Fisher Scientific · Aug 2023
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