(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 : Staphylococcus spp., modified by procedures, Haemophilus influenzae, Streptococcus pneumoniae.
Oxoid Azithromycin Susceptibility Test Disc
This document is a 510(k) submission for an antimicrobial susceptibility test disc. It does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, or performance metrics.
The document primarily states that the FDA has found the Azithromycin Antimicrobial Susceptibility Test Disc to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It mentions the "Indication for Use" and "Quality Control organisms" but does not delve into the specifics of a study conducted to prove the device meets acceptance criteria.
Therefore, I cannot provide the requested information from this document. To answer your questions, I would need a different type of document, such as a full clinical study report, a detailed performance evaluation, or a more comprehensive summary of the 510(k) submission that includes performance data.
§ 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).