(44 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 streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae. HardyDisk™ Aztreonam is indicated for in vitro activity against gram negative aerobic pathogens including Escherichia coli, Enterobacter spp., Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, and Citrobacter spp. HardyDisk™ Aztreonam is also indicated for in vitro activity against Haemophilus influenzae.
HardyDisk™ Antimicrobial Sensitivity Disks
I am sorry, but the provided text from the FDA 510(k) K994063 letter and accompanying "Indications for Use Statement" does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets those criteria.
The document is a regulatory approval letter for a device named "HardyDiskTM Aztreonam 30mcg" and its "Indications for Use Statement." It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use for antimicrobial susceptibility testing.
The document does NOT include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, or details about test sets.
- The number or qualifications of experts used for ground truth, or adjudication methods.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
- Results from a standalone algorithm performance study.
- The type of ground truth used for performance evaluation (e.g., pathology, outcomes data).
- Any information regarding a training set's sample size or how its ground truth was established.
This document is a formal communication of regulatory clearance, not a technical report detailing the performance study of the device. Such details would typically be found in the manufacturer's 510(k) submission, which is not provided here.
§ 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).