(51 days)
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. Nafcillin Susceptibility Test Discos are only for use with Staphylococcus spp.
Not Found
The provided text is a 510(k) clearance letter for a medical device: "Nafcillin Antimicrobial Susceptibility Test Disc." This document grants clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary that would describe acceptance criteria and performance data.
Therefore, I cannot provide the requested information from the given text. A 510(k) clearance letter confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate, allowing it to be marketed. It does not typically include the full scientific evidence or study details.
To answer your request, I would need access to the actual 510(k) submission summary or a separate clinical study report for the "Nafcillin Antimicrobial Susceptibility Test Disc."
§ 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).