(56 days)
Use of HardyDisk AST Ceftazidime/Avibactam, (30/20ug) - CZA50, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftazidime/Avibactam.
The concentration of Ceftazidime/Avibactam, (30/20ug) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with in vitro use: Morganii, Providencia rettgeri, and Serratia marcescens.
The concentration of Ceftazidime/Avibactam, (30/20ug) - CZA50, has been shown to be active against susceptible isolates of the following microorganisms with both in vitro and in clinical infections: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Citrobacter freundii, Citrobacter koseri, Proteus spp., and Enterobacter aerogenes.
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This document is a 510(k) clearance letter for an antimicrobial susceptibility test disc (Hardydisk AST Ceftazidime/Avibactam). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges the clearance of the device based on substantial equivalence to a predicate device, but it does not detail the specific performance metrics or studies performed.
Therefore, I cannot provide the requested information from the provided text.
§ 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).