(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, Staphylococcus spp., Pseudomonas spp., and by modified procedures, Haemophilus influenzae, and Streptococcus pneumoniae.
Not Found
The provided document is a 510(k) clearance letter from the FDA for an Antimicrobial Susceptibility Test Disc. It does not contain the specific details regarding acceptance criteria, study design, or performance metrics that would typically be found in a study report or a more detailed submission. Therefore, I cannot provide the requested information based on this document.
The document states:
- Device Name: Levofloxacin Antimicrobial Susceptibility Test Disc
- Indication for Use: "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., Pseudomonas spp., and by modified procedures, Haemophilus influenzae, and Streptococcus pneumoniae."
To answer your questions, I would need a different type of document, such as the full 510(k) submission, specifically the sections detailing the clinical or analytical performance 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).