(60 days)
Use of HardyDisk™ Ceftolozane/Tazobactam, (30/10µg) – C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam.
The concentration of Ceftolozane/Tazobactam, (30/10µg) – C/T40, has been shown to be active against susceptible isolates of the following microorganisms with in vitro use: Citrobacter koseri, Morganil, Proteus vulgaris, Providencia rettgeri. Providencia stuartii, Serratia liquefaciens, and Serratia marcescens.
The concentration of Ceftolozane/Tazobactam, (30/10µg) – C/T40, has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
HardyDisk™ AST 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, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
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This document is a marketing authorization letter for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Therefore, I cannot extract the requested information.
§ 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).