(15 days)
Use of HardyDisk™ Ceftaroline 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of Ceftaroline 30 µg has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoc, and Haemophilus influenza.
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The document provided is a 510(k) premarket notification letter for a medical device called "Hardy Disk Ceftaroline, 30μg," which is an antimicrobial susceptibility test disc. This document does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML powered device.
The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other compliance requirements for the manufacturer. The "Indications for Use" section lists the microorganisms against which the disc is active.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study detailed in the prompt, as this information is not present in the provided text.
§ 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).