(41 days)
HardyDisk™ Antimichobial 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. Sundardized methods for agar diffusion testing have been described for Enterotaciacae, Stuphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterocccus spp., other streptococci and, by modified procedures, Huemophilus influenque, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Doxycycline are indicated for in vitro activity against the Enterobacteriaciae, Acinetobacter spp., Staphylococcus spp., and Enterococcus spp.
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The document is a regulatory approval notice that states the device is "substantially equivalent" to legally marketed predicate devices. It does not include performance data, study designs, sample sizes, or information about ground truth establishment.
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§ 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).