(62 days)
Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Enterococcus spp., and modified by procedures, Haemophilus influenzae and Neisseria gonorthoeae.
Oxoid Cefotetan Susceptibility Test Disc
I am sorry, but based on the provided text, I cannot provide this information. The document is a 510(k) clearance letter from the FDA for a Cefotetan Antimicrobial Susceptibility Test Disc. It confirms that the device is substantially equivalent to previously marketed devices and allows it to proceed to market. However, it does not contain the detailed study results, acceptance criteria, or information about AI involvement that you are requesting. My purpose is to provide helpful and harmless information, and speculating about details not present in the document would be outside of my capabilities.
§ 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).