Literature DB >> 27923882

Why the New FDA Glucose Meter POCT Guidance Is Disappointing.

Jan S Krouwer1.   

Abstract

Entities:  

Keywords:  glucose meter; performance standard

Mesh：

Substances：

Year:  2016        PMID： 27923882      PMCID： PMC5951031          DOI： 10.1177/1932296816682763

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN： 1932-2968


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  4 in total

1.  Wrong thinking about glucose standards.

Authors:  Jan S Krouwer
Journal:  Clin Chem       Date:  2010-01-28       Impact factor: 8.327

2.  Why specifications for allowable glucose meter errors should include 100% of the data.

Authors:  Jan S Krouwer
Journal:  Clin Chem Lab Med       Date:  2013-08       Impact factor: 3.694

3.  The new glucose standard POCT12-A3 misses the mark.

Authors:  Jan S Krouwer
Journal:  J Diabetes Sci Technol       Date:  2013-09-01

Review 4.  A review of standards and statistics used to describe blood glucose monitor performance.

Authors:  Jan S Krouwer; George S Cembrowski
Journal:  J Diabetes Sci Technol       Date:  2010-01-01
  4 in total
  2 in total

1.  Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2019-04-11

Review 2.  Glucose biosensors in clinical practice: principles, limits and perspectives of currently used devices.

Authors:  Salvatore Andrea Pullano; Marta Greco; Maria Giovanna Bianco; Daniela Foti; Antonio Brunetti; Antonino S Fiorillo
Journal:  Theranostics       Date:  2022-01-01       Impact factor: 11.600
  2 in total

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