SPADA Meeting Book

(29) ISO 17511:2003, In vitro diagnostic medical devices—measurement of quantities in 1069 biological samples. Metrological traceability of values assigned to calibrators and control 1070 materials. International Organization for Standardization, Geneva, Switzerland. 1071 (30) Koch, D.D., & and Peters, T. (1999) in Tietz Textbook of Clinical Chemistry , Third Edition, 1072 C.A. Burtis & E.R. Ashwood (Eds), Saunders Co., Philadelphia, PA. 1073 (31) Westgard, J.O. (2008) Basic Method Validation , Third Edition, Westgard Quality 1074 Corporation, Madison, WI. 1075 (32) Clinical and Laboratory Standards Institute (2004) Evaluation of precision performance of 1076 quantitative measurement methods. Approved guideline, 2nd ed. CLSI document EP5-A2. 1077 Clinical and Laboratory Standards Institute, Wayne, PA . 1078 (33) Code of Federal Regulations (2009) 42 CFR 493.1253 - Standard: Establishment and 1079 verification of performance specifications. U.S. Government Printing Office, Washington 1080 DC, https://www.ecfr.gov/cgi-bin/text- 1081 idx?SID=dd25ed1e1fc03826036c4fa105249ccd&mc=true&node=pt42.5.493&rgn=div5#se 1082 42.5.493_11253 , accessed 30 May 2019. 1083 (34) Clinical and Laboratory Standards Institute (2003) Evaluation of the linearity of 1084 quantitative measurement procedures: a statistical approach. Approved guideline. CLSI 1085 document EP6-A, Clinical and Laboratory Standards Institute, Wayne, PA. 1086 (35) Food and Drug Administration, Section 564 of the Food Drug, and Cosmetic (FD&C) Act 1087 was amended by the Project Bioshield Act of 2004 and was further amended by the 1088 Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st 1089 Century Cures Act of 2016, and Public Law 115-92 of 2017. 1090

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