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The provided text is an FDA 510(k) clearance letter for a medical device (Thermo Scientific Oxoid Lefamulin Disc (20μg) LMU20), which is an antimicrobial susceptibility test disc. This kind of document typically does not include detailed information about the acceptance criteria and the study that proves the device meets them, as it is a summary of the FDA's decision, not the full submission.
Therefore, I cannot extract the requested information from the provided text.
The document only states:
- Device Name: Thermo Scientific Oxoid Lefamulin Disc (20μg) LMU20
- Regulation Name: Antimicrobial Susceptibility Test Disc
- Regulatory Class: Class II
- Product Code: JTN
To answer your questions, I would need access to the actual 510(k) submission document, which would contain the study protocols, results, and acceptance criteria.
§ 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).