(27 days)
HardyDisk" Autuniciplial Seusitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., I seudomonas spp., Acinetobacter spp., Listeria monocylogenes, Enterococcus spp., other streptococci and, by modified procedures, Ilaemophilus influenzae, Neisseria gonorrhoeae and Streptococcus preumoniae.
Hardy Disker Azithromycin is indicated for Staphylococcus spp., Streptococcus spp., including S. pncumoniae, and Haemophilus spp.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the HardyDisk™ Azithromycin 15mcg, a device used for semi-quantitative in vitro susceptibility testing. The letter determines substantial equivalence to a predicate device but does not contain the detailed study information or acceptance criteria requested.
Therefore, I cannot provide the requested information from the provided document. The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study report.
§ 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).