(25 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, Neisseria gonorrhoeae and Streptococcus spp.
Oxoid Loracarbef Susceptibility Test Disc
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (Loracarbef Antimicrobial Susceptibility Test Disc), and as such, it confirms the substantial equivalence of the device to a predicate device but does not detail the specific performance acceptance criteria or the study data used to demonstrate them. The letter mentions the "indications for use" but does not provide performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies.
§ 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).