(51 days)
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriaceae, Staphylococcus spp., and by modified procedures, Haemophilus influenzae.
Oxoid Cefprozil Susceptibility Test Disc
This document does not contain the detailed information needed to describe acceptance criteria and a study proving device performance in the way requested. The provided text is a 510(k) clearance letter from the FDA for a Cefprozil Antimicrobial Susceptibility Test Disc. It confirms that the device is substantially equivalent to a predicate device and can be marketed.
While it mentions "performance" in a general sense within the context of device regulation, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study, sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Specifics on how ground truth was established for training or test sets.
Essentially, the FDA clearance letter indicates the device met the requirements for substantial equivalence, but it does not present the data from the study that led to that determination. To answer your questions, one would need access to the actual 510(k) submission document itself, which would contain the performance data and study details.
§ 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).