(72 days)
HardyDisk™ Antimicrobial Sensitivity 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., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes Enterococcus spp., other streptaceae and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.
HardyDisk™ Oxacillin is indicated for in vitro activity against Staphylococcur spp. and Streptococcus pneumoniae.
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The provided text is a 510(k) premarket notification letter from the FDA to Hardy Diagnostics regarding their HardyDisk™ Oxacillin 1mcg device. This document confirms the substantial equivalence of the device to existing predicate devices. However, the letter itself does not contain the detailed acceptance criteria for the device's performance, nor does it provide a report of a study that proves the device meets such criteria.
The letter indicates that the device is "substantially equivalent" to legally marketed predicate devices, implying that testing was conducted to demonstrate this equivalence. However, the specific details of that testing, including the acceptance criteria, study design, sample sizes, ground truth establishment, and expert qualifications, are not included in this document. Such information would typically be found in the 510(k) submission itself, which is not provided here.
Therefore, I cannot answer the questions based solely on the provided text. The document is a regulatory approval letter, not a scientific study report.
§ 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).