Analytical sensitivity: This section should include information about the study design and results. It should provide a description of specimen type and preparation including matrix, analyte (measurand) levels, and how levels were established. The number of replicates tested at each concentration should also be provided as well as a description of the calculation used to determine assay sensitivity. For example: (a) Number of standard deviations above the mean value of the sample without analyte (measurand), commonly referred to as limit of blank (LoB). (b) Lowest concentration distinguishable from zero, based on measurements of samples containing analyte (measurand), commonly referred to as limit of detection (LoD). (c) Lowest concentration at which precision and / or trueness are within specified criteria, commonly referred to as limit of quantitation (LoQ).For Class C and D in vitro diagnostic medical devices, detailed information would be provided