Review Book

19. Are there any concerns regarding the safety of the method? Please refer to the review provided by the Safety Advisor. Reviewer 1 No (Safety review not provided) Reviewer 2 NO Reviewer 3 NO Reviewer 4 Please see Safety Advisor review Reviewer 5 NO Reviewer 6 None Safety Advisor SAFETY ADVISOR'S RECOMMENDATION:

A. The method contains appropriate precautions and potential hazards have been identified corresponding to the approved study protocol and safety guidance. GENERAL COMMENTS ABOUT THE METHOD 1. 17(12) ‐ (g) “…cleaned and decontaminated” is also Safety. (also in IFU) 2. 17(12) ‐ 1st paragraph of Safety should be added to IFU. EDITORIAL EVALUATION CRITERIA Comments: N/A Are there any concerns regarding the safety of the method? (if necessary, refer to the review from the Safety Advisor)? No Are there any concerns regarding the data manipulation, data tables or statistical analyses (if necessary, refer to the review from the Statistics Advisor)? See Statistical Review

20. Are there any concerns regarding the data manipulation, data tables, or statistical analysis? Please refer to the review provided by the Statistical Advisor. Reviewer 1 NO (Statistical review not provided) Reviewer 2 Report Pending Reviewer 3 NO Reviewer 4 Please see Statistical Advisor review Reviewer 5 NO Reviewer 6 No comment Statistics Advisor

Does the statistical design of the study support the applicability statement? (i.e., Do the matrices, analytes and concentrations cover the applicability?) Yes Are there sufficient data points per product/method evaluated (i.e., number of laboratories, number of replicates per laboratory)? Yes If data is pooled, is it clear that variances are homogeneous? No If applicable, has statistics been calculated for Sr, SMR, RSDr, RSDR, r, R, HORRAT and Percent Recovery (see Part 6)? No If so, have the calculations been done correctly?