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HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

HardyDisk™ Mezlocillin is indicated for in vitro activity against the Enterobacteriaciae, Pseudomonas aeruginosa and Acinetobacter spp.,

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This document is a 510(k) clearance letter from the FDA for a medical device, specifically the HardyDisk™ Mezlocillin, 75mcg. This type of document is a regulatory approval and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes for test/training, expert qualifications, etc.) that you are asking for.

The letter confirms that the FDA has reviewed the manufacturer's submission and determined that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided in the original 510(k) submission by Hardy Diagnostics, which would have included details of their testing and validation.

Therefore, it is not possible to extract the requested information from the provided text. The text only states the device's indications for use:

• Device Name: HardyDisk™ Mezlocillin, 75mcg
• Intended Use: Semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens.
• Specific Organisms (for Mezlocillin): Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter spp.

To obtain the information you requested, you would need to access the original 510(k) submission document (K994212) filed by Hardy Diagnostics with the FDA, which would detail the studies conducted to demonstrate substantial equivalence.

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