(71 days)
HardyDisk™ Antimicrobial Seasitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test proccdure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial vathogens. Standardized methods for agar diffusion testing have been described for Euterobacteriaccas, Staphylococcus spp., Pseudomonas spn., Acinetobacter spp., Listerta monocytogenes, Enterococcus spp., other streptococci and, hy modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
Hardy Disk™ Erythromycin is indicated for in vitro activity against Staphylococcus spp., and Streptococcus spp. including S. pneumoniae.
HardyDisk™ Erythromycin 15mcg is an antimicrobial sensitivity disk.
The provided text is a 510(k) premarket notification letter from the FDA to Hardy Diagnostics for their HardyDisk™ Erythromycin 15mcg. While it confirms the device's substantial equivalence to a predicate device and its regulatory classification, it does not contain the detailed study information or acceptance criteria requested.
Therefore, I cannot provide a response filling out the requested table and study details. The document is primarily a regulatory approval letter and an "Indications for Use Statement."
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).