Essential Agreement Ast
It is difficult for the FDA to determine an essential equivalence for a product, if the results of the overall reproducibility study of all test sites for antimicrobial active substances XII. Labelling that indicates that users should not communicate the results. This type of restriction may apply if certain procedural options (unocumed method, reading method, etc.) were deemed unacceptable, while another was acceptable. The evaluation criterion of the Etest method was a 90% blockage of growth when reading with reflected light, as indicated in the leaflet. With this criterion, the Etest method showed compliance values of 90.0 and 92.0% respectively, 90.0% and 92.0% compared to the results of the reference method for broth micro-backflow. Etest had the highest percentage of very large errors for staphylococci (40.0%) among all MIC-based methods. Strains S. aureus 3213, 3487, 3036, 5721 and 1458 and strain S. epidermidis 7338 all produced very large errors (Table 2.2), as well as one strain E. faecium (3419). Two of the very large errors (strains 3036 and 7338) were corrected following a new test by Etest (i.e.
non-vulnerable results). None of the very large errors were performed with isolates that gave a slight growth. Three minor errors, all with E. faecium strains, were also observed. As a general rule, the FDA recommends that you define the performance of your AST product according to the CLSI standard reference method for each antimicrobial active substance and the organisms to be tested. Since variations in test procedures can affect performance, we believe that you should conduct amicable studies on all procedure options included in the “Instructions for Use” section of the package leaflet. Such procedural options, but are not limited to methods of preparing for vaccination and reading the results, for example: they should also address all possible combinations of these options. For example, if you add manual or automated vaccinations and/or visual or automated reading methods, you need to perform additional tests such as agreement studies, challenge, QC, reproducibility. and acceptable performance for each procedure option.
You must provide this data with your 510(k) repository for each new method that users need to use. However, if you define a specific method as “secondary”, you should only include tests for QC, reproducibility, and Challenge panels. In contrast to the poor performance of ast systems for the determination of the MIC of the three QC strains, the BMD method gave excellent results, with all MICs (100%) within the expected reference areas. In addition, the TRIMs of the two isolates in the study (S1 and S2) were 100% consistent with several antimicrobial active substances, such as those performed by each of the three central laboratories (Table S9). S1 showed vulnerability or intermediate vulnerability to most antimicrobials other than ampicillin (AMP), pipeacillin (PIP), CZO, CXM, ceftriaxone (CRO), CIP, levofloxacin (LVX) and SXT, while S2 had resistance to all antibiotics with moderate sensitivity to TBI. . . .