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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for micafungin in the dilution range of 0.008-16 ug/mL for testing Candida spp. on The Sensitite YeastOne Susceptibility System. Micafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida guilliermondi Candida krusei Candida parapsilosis Candida tropicalis

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VITEK 2 AST-Yeast Voriconazole 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 Voriconazole is a quantitative test. Voriconazole 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 krusei 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.

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique. The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique. 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 Voriconazole has the following concentrations in the card: 0.03125, 0.125, 0.25, 1, and 2 (equivalent standard method concentration by efficacy in ug/mL).

VITEK 2 AST-Yeast Anidulafungin 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 Anidulafungin is a quantitative test. Anidulafungin 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 glabrata Candida parapsilosis Candida tropicalis In vitro data are available, but clinical significance is unknown: Candida guillermondii Candida krusei 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.

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 Anidulafungin has the following concentrations in the card: 0.0625, 0.125, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL).

The Sensitite YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candido spp. This 510(k) is for Rezafungin in the dilution range of 0.008 - 8 ug/mL for testing Candida spp. on the Sensititer YeastOne Susceptibility System. Rezafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drup label: Candida albicans Candida glabrata Candida parapsilosis.

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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Fluconazole with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Fluconazole has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida parapsilosis

The Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Caspofungin with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System. Caspofungin has been shown to be active both clinically and in viro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

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Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008-8 ug/mL

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VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and clinical infections: - Candida albicans - Candida glabrata Candida guilliermondii - Candida krusei - Candida parapsilosis - Candida tropicalis The VITEK @ 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinically significant yeast.

VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial aqents.

VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinically significant yeast.

The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 COMPACT has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

VITEK® 2 AST-YS Caspofungin 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 antimicrobial agents. VITEK® 2 Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifyingal. Active in vitro and clinical infections: Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK @ 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. pneumoniae, and clinically significant yeast.

The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.