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Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., and by modified procedures, Haemophilus influenzae, and Streptococcus pneumoniae.

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The provided document is a 510(k) clearance letter from the FDA for an Antimicrobial Susceptibility Test Disc. It does not contain the specific details regarding acceptance criteria, study design, or performance metrics that would typically be found in a study report or a more detailed submission. Therefore, I cannot provide the requested information based on this document.

The document states:

• Device Name: Levofloxacin Antimicrobial Susceptibility Test Disc
• Indication for Use: "Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., and by modified procedures, Haemophilus influenzae, and Streptococcus pneumoniae."

To answer your questions, I would need a different type of document, such as the full 510(k) submission, specifically the sections detailing the clinical or analytical performance studies.

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