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VITEK® 2 Streptococcus Levofloxacin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Levofloxacin 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 agents. Levofloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]) Streptococcus pyogenes

Active in vitro but clinical significance unknown β-hemolytic Streptococcus (Group C/F) B-hemolytic Streptococcus (Group G) Streptococcus agalactiae Streptococcus milleri Viridans group Streptococci

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. and clinically significant yeast.

The VITEK 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). 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 cvcle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

The VITEK 2 Streptococcus Levofloxacin has the following concentrations in the card: 1. 2. 4 and 16 ug/mL (equivalent standard method concentration by efficacy in ug/mL). The MIC result range for the VITEK 2 card is ≤ 0.25 -> 16ug/mL.

This document describes the VITEK® 2 Streptococcus Levofloxacin system, a device for antimicrobial susceptibility testing of Streptococcus species, and its performance evaluation for FDA 510(k) clearance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VITEK® 2 Streptococcus Levofloxacin system are not explicitly stated as quantitative thresholds in the provided text. However, standard AST guidance documents and FDA interpretive criteria are referenced, implying the following would be the acceptance criteria. The reported device performance is derived from the "Method comparison with predicate device" section.

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