(33 days)
Use of HardyDisk™ Meropenem/Vaborbactam 20/10ug (MEV30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of bacteria to Meropenem/Vaborbactam.
Meropenem/Vaborbactam has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae
Meropenem/Vaborbactam has been shown to be active in vitro against susceptible isolates of the following
microorganisms: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus mirabilis Providencia spp. Pseudomonas aeruginosa Serratia marcescens.
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the HardyDisk™ Meropenem/Vaborbactam 20/10ug (MEV30). This document is a regulatory approval, not a scientific study report describing the device's performance in detail.
Therefore, the information requested for a study proving device performance against acceptance criteria (sections 1-9) cannot be extracted from this document.
This document primarily states:
- The device name and intended use (susceptibility testing of bacteria to Meropenem/Vaborbactam).
- The FDA's determination of substantial equivalence to predicate devices.
- Regulatory classifications and requirements.
It does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Details on expert involvement, ground truth establishment, or study methodologies (e.g., MRMC studies, standalone performance).
To answer your request, a detailed performance study report (e.g., clinical trial report, validation study report) for the HardyDisk™ device would be required.
§ 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).