Search Results

HardyDisk® Antimierobial Seusilivity Disks are used for scini-quantitative in vitro susceptibility testing by the agat diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bactcrial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaces, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influerizae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

HardyDisk™ Gentomicin is indicated for in vitro activity against the Enterobacteriaciae, Pscudomonas acruginosa, and Staphylococcus spp.

Not Found

This document is a 510(k) clearance letter from the FDA for the HardyDisk™ Gentamicin 10mcg, an antimicrobial susceptibility disk. It does not contain the detailed acceptance criteria or a study describing how the device meets those criteria in the format requested.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that comparative studies would have been submitted to the FDA to demonstrate this equivalence, but the letter itself does not contain the details of those studies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

Ask a specific question about this device