Clinical Validation Protocols for Blood Glucose Meters
ISO/IEC/CEN/DIN
15197:2013
International Organization for Standardization Technical Committees ISO/TC 212 and ISO/TC 140. ISO 15197:2013, In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: ISO; 2013. Preview available here.
idem quod
Comité Européen de Normalisation CEN/TC 140. EN ISO 15197:2015, In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: CEN; 2015 Jun 10.
idem quod
Федеральное Агентство по Техническому Регулированию и Метрологии (Российской Федерации). ГОСТ Р ИСО 15197-2015, Тест-системы для диагностики in vitro. Требования к системам мониторинга глюкозы в крови для самоконтроля при лечении сахарного диабета. Москва, Россия: Москва Стандартинформ; 2015. [Federal Agency for Technical Regulation and Metrology (Russian Federation) GOST R ISO 15197-2015, In vitro diagnostic test systems. Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. Moscow, Russia: Moscow Standard-Inform; 2015.] Information here
DTS
DTS:2016
Klonoff DC, Lias C, Beck S, Parkes JL, Kovatchev B, Vigersky RA, Arreaza-Rubin G, Burk RD, Kowalski A, Little R, Nichols J, Petersen M, Rawlings K, Sacks DB, Sampson E, Scott S, Seley JJ, Slingerland R, Vesper HW. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol. J Diabetes Sci Technol. 2016 May 3;10(3):697-707. doi: 10.1177/1932296815614587. PMID: 26481642. Download here
FDA
FDA:2020P
US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Radiological Health, Division of Chemistry and Toxicology Devices. Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use – Guidance for Industry and Food and Drug Administration Staff. Rockville, Maryland, USA: FDA; 2020. Download here
FDA:2020H
US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Radiological Health, Division of Chemistry and Toxicology Devices. Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use – Guidance for Industry and Food and Drug Administration Staff. Rockville, Maryland, USA: FDA; 2020. Download here
CLSI
CLSI:2013
Clinical and Laboratory Standards Institute. CLSI POCT12 A3 Ed. 3 (2013), Point-of-care Blood Glucose Testing in Acute and Chronic Care Facilities. Wayne, Pennsylvania, USA: CLSI; 2013.
CLSI:2008
Klonoff D, Bernhardt P, Ginsberg BH, Joseph J, Mastrototaro J, Parker DR, Vesper H, Vigersky R. CLSI POCT05-A Ed. 1 (2008), POCT05-A: Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline. Wayne, Pennsylvania, USA: CLSI; 2008. Information here
EP09:2018
Budd JR, Durham AP, Gwise TE, Hawkins DM, Holland M, Iriarte B, Kallner, A, Linnet K, Magari R, Vals JE. Measuerment Procedure Comparison and Bias estimation Using Patient Samples; Approved Guideline - Corrected Third Edition. CLSI document EP09c. Wayne, PA, USA: Clinical and Laboratory Standards Institute 2018 Jun 20;38(12).
Chinese Medical Association
CMA:2016
中华医学会检验医学分会 [Chinese Medical Association, Laboratory Medicine Branch]. 便携式血糖仪临床操作和质量管理规范 中国专家共识 [Portable blood glucose meter clinical operation and quality management practices – Chinese expert consensus]. 中华医学杂志 [Natl Med J China] 2016 Sep 27;96(36):2864–7. Download here
ISO/IEC/CEN/DIN
15197:2011
Межгосударственный совет по стандартизации, метрологии и сертификации. ГОСТ ISO 15197-2011, Системы диагностические in vitro. Требования к системам мониторного наблюдения за концентрацией глюкозы в крови для самоконтроля при лечении сахарного диабета. Москва, Россия: МГС; 2013. [EuroAsian Interstate Council for Standardization, Metrology and Certification GOST ISO 15197-2011, In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Moscow, Russia: EASC; 2013.] Information here
15197:2003
International Organization for Standardization Technical Committee ISO/TC 212. EN ISO 15197:2003, In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: ISO; 2003. Information here
15197:2002
International Organization for Standardization. DIN EN ISO 15197:2002, Determination of performance criteria for in vitro blood glucose monitoring systems for management of human diabetes mellitus. ISO 15197. Geneva, Switzerland: ISO; 2002.
15197:2001
International Organization for Standardization. ISO Draft International Standard 15197.2, In vitro diagnostic systems —Requirements for in vitro blood glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: ISO; 2001.
FDA
FDA:2016P
US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Radiological Health, Division of Chemistry and Toxicology Devices. Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use – Guidance for Industry and Food and Drug Administration Staff. Rockville, Maryland, USA: FDA; 2016.
FDA:2016H
US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Radiological Health, Division of Chemistry and Toxicology Devices. Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use – Guidance for Industry and Food and Drug Administration Staff. Rockville, Maryland, USA: FDA; 2016.
FDA:1989
U.S. Food and Drug Administration. Review criteria for assessment of portable invasive blood glucose monitoring in vitro diagnostic devices which use glucose oxidase, dehydrogenase, or hexokinase methodology. Silver Spring, Maryland, USA: FDA; 1989. Information here
CLSI/NCCLS
CLSI:2002
Clinical and Laboratory Standards Institute. CLSI C30 A2 Ed. 2 (2002), Point-of-care Blood Glucose Testing in Acute and Chronic Care Facilities. Wayne, Pennsylvania, USA: CLSI; 2002.
CLSI:1994
National Committee for Clinical Laboratory Standards. NCCLS C30 A:1994, Ancillary (bedside) blood glucose testing in acute and chronic care facilities. Wayne, Pennsylvania, USA: CLSI; 1994.
CLSI:1991
National Committee for Clinical Laboratory Standards. NCCLS C30 T:1991, Ancillary (bedside) blood glucose testing in acute and chronic care facilities. Wayne, Pennsylvania, USA: CLSI; 1991.
EP09:2013
Budd JR, Durham AP, Gwise TE, Iriarte B, Kallner, A, Linnet K, Magari R, Vals JE. Measuerment Procedure Comparison and Bias estimation Using Patient Samples; Approved Guideline - Third Edition. CLSI document EP09-A3. Wayne, PA, USA: Clinical and Laboratory Standards Institute 2013 Aug 20;33(11).
EP09:2010
Krouwer JS, Tholen DW, Garber CC, Goldschmidt HMJ, Kroll MH, Linnet K, Meier K, Robinowitz M, Kennedy JW. Method Comparison and Bias estimation Using Patient Samples; Approved Guideline - Second Edition (Interim Revision). CLSI document EP09-A2-IR. Wayne, PA, USA: Clinical and Laboratory Standards Institute 2010 Jul;30(17).
EP09:2002
Krouwer JS, Tholen DW, Garber CC, Goldschmidt HMJ, Kroll MH, Linnet K, Meier K, Robinowitz M, Kennedy JW. Method Comparison and Bias estimation Using Patient Samples; Approved Guideline - Second Edition. CLSI document EP9-A2. Wayne, PA, USA: The National Committee for Clinical Laboratory Standards (Clinical and Laboratory Standards Institute) 2002 Sep;22(19).
EP09:1995
Kennedy JW, Carey RN, Coolen RB, Garber CC, Lee HT, Levine JB, Osberg IM. Method Comparison and Bias estimation Using Patient Samples; Approved Guideline. CLSI document EP9-A. Wayne, PA, USA: The National Committee for Clinical Laboratory Standards (Clinical and Laboratory Standards Institute) 1995 Dec;15(17).
ADA
ADA:1996
American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1996;19(Suppl 1):S62-S66. doi: 10.2337/diacare.19.1.S62. PMID: 8689936. Information here
ADA:1994
American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1994;17(1):81-6. doi: 10.2337/diacare.17.1.81. PMID: 8112195. Information here
ADA:1987
American Diabetes Association. Consensus statement on self monitoring of blood glucose. Diabetes Care. 1987;10(1):95-9. doi: 10.2337/diacare.10.1.95. PMID: 3552518. Information here
CSA
CSA:1999
Canadian Standards Association. CSA Z316.4-94 (R2000), Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management. Toronto, Ontario, Canada: CSA; 1999. Information here
CSA:1994
Canadian Standards Association. CSA Z316.4-94, Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management. Mississauga, Ontario, Canada: CSA; 1994