(55 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 Pseudomonas spp., and by modified procedures, Neisseria gonorrhoeae.
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This document is a 510(k) premarket notification decision letter from the FDA for the Oxoid Enoxacin Susceptibility Test Disc, along with a portion of the 510(k) submission itself.
The document does not contain any information about acceptance criteria or the study that proves the device meets those criteria. It is solely a regulatory approval document.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other questions about study design, sample sizes, ground truth, or expert qualifications, as that information is not present in 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).