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Journal Abstract Search
137 related items for PubMed ID: 28587476
1. Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197? Freckmann G, Baumstark A, Pleus S. J Diabetes Sci Technol; 2017 Nov; 11(6):1240-1246. PubMed ID: 28587476 [Abstract] [Full Text] [Related]
2. Why the New FDA Glucose Meter POCT Guidance Is Disappointing. Krouwer JS. J Diabetes Sci Technol; 2017 Nov; 11(6):1274. PubMed ID: 27923882 [No Abstract] [Full Text] [Related]
4. 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. Freckmann G, Schmid C, Baumstark A, Rutschmann M, Haug C, Heinemann L. J Diabetes Sci Technol; 2015 Jul; 9(4):885-94. PubMed ID: 25872965 [Abstract] [Full Text] [Related]
5. Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models. Lyon AW, Lyon ME. J Diabetes Sci Technol; 2020 May; 14(3):513-518. PubMed ID: 31752535 [Abstract] [Full Text] [Related]
13. Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197. Jendrike N, Baumstark A, Pleus S, Mende J, Haug C, Freckmann G. J Diabetes Sci Technol; 2019 Mar 01; 13(2):235-241. PubMed ID: 30547683 [Abstract] [Full Text] [Related]
18. ISO 15197:2013 Accuracy Evaluation of Two CE-Marked Systems for Self-Monitoring of Blood Glucose. Jendrike N, Rittmeyer D, Pleus S, Baumstark A, Haug C, Freckmann G. J Diabetes Sci Technol; 2015 Jul 01; 9(4):934-5. PubMed ID: 25901021 [No Abstract] [Full Text] [Related]