(21 days)
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus spp.
Not Found
This FDA document is a 510(k) clearance letter for the Oxoid Cefpodoxime Antimicrobial Susceptibility Test Disc. It does not contain a detailed study report with acceptance criteria and device performance. The letter simply states that the device is "substantially equivalent" to predicate devices.
Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on regulatory approval based on substantial equivalence, not on the detailed results of a performance study.
§ 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).