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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 aeruginosa ,and by modified procedures, and Streptococcus spp. This submission is for the use of Sparfloxacin with Staphylococcus spp. and Streptococcus pneumoniae.

Oxoid Sparfloxacin Susceptibility Test Disc

This looks like a 510(k) clearance letter for a medical device from the FDA, specifically for a Sparfloxacin Antimicrobial Susceptibility Test Disc. Unfortunately, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it's typically found in a detailed study report or a summary of safety and effectiveness, not in the FDA's clearance letter itself.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to a predicate device.
• Outlining regulatory requirements and points of contact for the manufacturer.
• Stating the intended use of the device.

To provide the requested information, I would need a different document, such as:

• The actual 510(k) submission summary (often referred to as the "summary of safety and effectiveness" or "510(k) summary").
• A clinical study report for the device.
• A performance testing report for the device.

Without these specific types of documents, I cannot extract details about acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

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