(70 days)
HardyDisk™ Chloramphenicol Antinuicobial Seusitivity Disks are used for semi-quantiarive in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bactcrial pathogens. Standardized methods for agar diffusion icsting have been described for Entcrobactcriaccas, Staphylococcus spp., I seudomonas aeruginusu, Acinctobacter spp., Eisteria monocytogenes, Enterococcus spp., other streptococi and, by modified procedures; Huemophilus influcitzae, and streptococci, including Streptococcus рпеитопіав.
HardyDisk™ Chloranophenicol is indicated for in vitro activity against the Enterobacteriaciae, Staphylococcus spp., Haemophilus spp., and Streptococous spp., including Streptococcus pneumoniae.
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The provided text is a 510(k) clearance letter from the FDA for a device called "HardyDiskTM Chloramphenicol 30mcg," which is an antimicrobial susceptibility disk. This document does not contain information about acceptance criteria, device performance tables, study details like sample sizes, ground truth establishment, or multi-reader multi-case studies.
The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device's performance aligns with established standards for such devices, but the specific performance metrics and a detailed study report are not part of this regulatory clearance document.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, and performance statistics based 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).