(56 days)
Use of HardyDisk AST Ceftolozane Tazobactam, (30/10μg) - C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam. The concentration of Ceftolozane/Tazobactam, (30/10µg) - C/T40, has been shown to be active against most isolates of Pseudomonas aeruginosa both in vitro and in clinical infections.
HardyDisk AST Ceftolozane/Tazobactam. (30/10ug) - C/T40 is an Antimicrobial Susceptibility Test Disc.
This document does not contain information about acceptance criteria and study results in the typical format of a device performance report. It is an FDA 510(k) clearance letter for the HardyDisk AST Ceftolozane/Tazobactam. As such, it confirms the device's substantial equivalence to a predicate device for its indicated use but does not directly present the detailed acceptance criteria and study data.
Therefore, I cannot populate the table or answer most of the questions you asked based on the provided text.
However, I can extract the following relevant information:
1. Device Name and Indication for Use:
- Device Name: HardyDisk AST Ceftolozane/Tazobactam, (30/10μg) - C/T40
- Indications for Use: "Use of HardyDisk AST Ceftolozane Tazobactam, (30/10μg) - C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam. The concentration of Ceftolozane/Tazobactam, (30/10µg) - C/T40, has been shown to be active against most isolates of Pseudomonas aeruginosa both in vitro and in clinical infections."
The letter indicates that the FDA has reviewed a 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the company would have submitted data demonstrating this equivalence, likely including performance data against predefined criteria, but these specific criteria and the detailed study results are not included in this document.
Based on the available text, I cannot provide the specific details requested in your prompt regarding acceptance criteria, study design parameters, and results. These would typically be found in the 510(k) submission itself, not in the 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).