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VITEK® 2 AST-GP Cefoxitin Screen is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. It 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.

The VITEK® 2 Gram-Positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and Streptococcus agalactiae to antimicrobial agents when used as instructed.

VITEK® 2 AST-GP Cefoxitin Screen is designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. The cefoxitin screen and oxacillin work in combination to determine the final interpretation reported for oxacillin. The VITEK® 2 AST-GP Cefoxitin Screen is a qualitative test based on the CLSI, "Disk Diffusion Test for Prediction of mecAmediated resistance in Staphylococci." The VITEK® 2 AST-GP Cefoxitin Screen test 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.

The VITEK® 2 card is inoculated with a standardized organism suspension, and growth inside the card is optically monitored throughout the incubation cycle. Results are automatically calculated once a predetermined growth threshold is reached and a report is generated that contains the MIC result and the interpretive category result.

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh('') 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. For the VITEK 2 Cefoxitin Screen, the report will list either a positive or negative result. The VITEK 2 Cefoxitin Screen and oxacillin work in combination to determine the final oxacillin interpretation based on the CLSI recommendations.

NOTE: Final determination of the oxacillin interpretation is based on forcing rules as managed by the VITEK 2 Systems software. Both the VITEK 2 AST-GP Cefoxitin Screen test and Oxacillin test must finalize before any forcing rules are applied.

VITEK® 2 AST-GP Cefoxitin Screen has the following concentrations in the card: 4 and 5 ug/mL (equivalent standard method concentration by efficacy in ug/mL).

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a qualitative test designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp. The performance is measured by Category Agreement (CA) and various error rates (Very Major Error - VME, Major Error - ME, Minor Error - mE).

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