Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_29
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 29
Character Range: 301526–302450

29    For an IVD medical device, information (including, to the extent practicable, drawings and diagrams) about the following:
      (a) the scientific principle (the 'test principle') on which the performance of the IVD medical device relies;
      (b) specimen type, collection, handling and preparation;
      (c) reagent description and any limitations (for example, use with a dedicated instrument only);
      (d) assay procedure including calculations and interpretation of results;
      (e) interfering substances and their effect on the performance of the assay;
      (f) analytical performance characteristics, such as sensitivity, specificity, accuracy and precision;
      (g) clinical performance characteristics, such as sensitivity and specificity;
      (h) reference intervals, if appropriate;
      (i) any precautions to be taken in relation to substances or materials that present a risk of infection