(51 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, Staphylocouss spp., and by modified procedures, Haemophilus influenzae.
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The provided text is a 510(k) clearance letter for a medical device: "Cefonicid Antimicrobial Susceptibility Test Disc." This document is a regulatory communication from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria, study design, or performance metrics of the device itself. It is a clearance letter, not a scientific study report or a summary of performance data.
Therefore, I cannot provide the requested information based solely on this input. The letter essentially states that the device is cleared for market based on its substantial equivalence to existing products, but it does not detail the specific studies or performance data that led to this determination.
To answer your questions, I would need access to the actual 510(k) submission document, specifically the sections dealing with performance data, clinical studies, or non-clinical studies.
§ 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).