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. 2017 Nov;11(6):1274.
doi: 10.1177/1932296816682763. Epub 2016 Dec 5.

Why the New FDA Glucose Meter POCT Guidance Is Disappointing

Jan S Krouwer  1
Affiliations

Why the New FDA Glucose Meter POCT Guidance Is Disappointing

Jan S Krouwer. J Diabetes Sci Technol. 2017 Nov.
No abstract available

Keywords: glucose meter; performance standard.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JSK is an employee of Krouwer Consulting.

References

    1. Krouwer JS. Wrong thinking about glucose standards. Clin Chem. 2010;56:874-875. - PubMed
    1. Krouwer JS, Cembrowski GS. A review of standards and statistics used to describe blood glucose monitor performance. J Diabetes Sci Technol. 2010;4:75-83. - PMC - PubMed
    1. Krouwer JS. Why specifications for allowable glucose meter errors should include 100% of the data. Clin Chem Lab Med. 2013;51:1543-1544. - PubMed
    1. Clinical and Laboratory Standards Institute. POCT12-A3 Point-of-care blood glucose testing in acute and chronic care facilities; approved guideline—third edition.
    1. Krouwer JS. The new glucose standard, POCT12-A3 misses the mark. J Diabetes Sci Technol. 2013;7:1400-1402. - PMC - PubMed

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