VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

• K Number: K213241
• Device Name: VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
• Manufacturer: BioMerieux, Inc.
• Date Cleared: 2022-02-25 ( 148 days)
• Product Code: LON
• Regulation Number: 866.1645
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: K133817

Intended Use

VITEK® 2 AST-Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK® 2 AST-Yeast Fluconazole is a quantitative test. Fluconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and in clinical infections: Candida albicans Candida parapsilosis Candida tropicalis

The VITEK® 2 Fungal Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

Device Description

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach (2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).

Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK® 2 AST-YS Fluconazole has the following concentrations in the card: 2, 4, 8, 16, 32, and 64 (equivalent standard method concentration by efficacy in us/mL).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 AST-Yeast Fluconazole device, based on the provided document:

Acceptance Criteria and Device Performance

Criteria Type	Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (EA)	Not explicitly stated as a numerical threshold in the provided text, but the study was designed to confirm "acceptability" by comparison to the CLSI broth microdilution reference method. Commonly, 90% or higher is expected for FDA clearance of AST systems.	96.2% overall Essential Agreement with the CLSI broth microdilution reference method when testing C. albicans, C. parapsilosis, and C. tropicalis.
Specifically, for Candida parapsilosis, an overall essential agreement rate of 99.1% was observed.
Overall Category Agreement (CA)	Not explicitly stated as a numerical threshold in the provided text, but the study was designed to confirm "acceptability" by comparison to the CLSI broth microdilution reference method. Commonly, 90% or higher is expected for FDA clearance of AST systems.	93.7% overall Category Agreement with the CLSI broth microdilution reference method when testing C. albicans, C. parapsilosis, and C. tropicalis.
Specifically, for Candida parapsilosis, an overall category agreement rate of 94.5% was observed.
Very Major Errors (VME)	Not explicitly stated as a numerical threshold, but VME are generally expected to be very low, typically

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”