(91 days)
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 Enterobacterales, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterocccus spp., and by modified procedures, Candida spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Use of HardyDisk™ AST Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Cefiderocol.
HardyDisk™ AST Cefiderocol at concentration 30μg can be used to determine the zone diameter (mm) of Cefiderocol against the following microorganisms.
Active both in vitro and clinical infections against: Gram-negative bacteria Escherichia coli Enterobacter cloacae complex Proteus mirabilis Pseudomonas aeruginosa Acinetobacter baumannii complex Klebsiella pneumoniae Serratia marcescens
Active in vitro against: Gram-negative bacteria Citrobacter freundii complex Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri
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.
This document, K241060, is a 510(k) premarket notification for the HardyDisk AST Cefiderocol 30μg (FDC30), an antimicrobial susceptibility test disc. It describes the device's indications for use and states that it has been determined substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain information about the acceptance criteria or the study that proves the device meets those criteria.
The document is a clearance letter from the FDA, confirming the substantial equivalence of the device. It outlines regulatory requirements and general controls but does not include the technical study report, validation data, or specific performance metrics (like sensitivity, specificity, accuracy, etc.) that would be necessary to answer your questions regarding acceptance criteria and study details.
Therefore, I cannot provide the requested information from this document. To answer your questions, I would need access to the actual study report or the detailed premarket submission data that was reviewed by the FDA, which is not part of this clearance letter.
§ 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).