title: Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.
abstract: In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems.
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany guido.freckmann@uni-ulm.de.
authors: Guido
authors: G
authors: Freckmann
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Christina
authors: C
authors: Schmid
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Annette
authors: A
authors: Baumstark
authors: Edingen-Neckarhausen, Germany.
authors: Malte
authors: M
authors: Rutschmann
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Cornelia
authors: C
authors: Haug
authors: Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.
authors: Lutz
authors: L
authors: Heinemann
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood*; D005060:Europe; D017408:Guidelines as Topic; D006400:Hematocrit; D006801:Humans; D007003:Hypoglycemia / Q000175:diagnosis; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001786:Blood Glucose
keywords: FDA draft guidance document; ISO 15197:2003; ISO 15197:2013; SMBG systems; blood glucose monitoring; system accuracy