(64 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™ Cefaclor is indicated for in vitro activity against the Enterobacteriacieae, methicillin sensitive Staphylococcus spp., non-beta lactamase producing Haemophilus spp. and Moraxella catarrhalis.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Hardy Diagnostics for their HardyDisk™ Cefaclor 30mcg device. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining regulatory obligations for marketing the device.
- Providing contact information for further inquiries.
The "Indications for Use Statement" on page 2 describes what the device is for (semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure) and the types of bacteria and organisms it is indicated for. However, it does not detail performance metrics, study designs, or results that would demonstrate its effectiveness or adherence to specific acceptance criteria.
Therefore, it is impossible to complete the requested table and answer the study-related questions based on the provided document.
§ 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).