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

Author:

Krouwer Jan S.1

Affiliation:

1. Krouwer Consulting, 26 Parks Drive, Sherborn, MA 01770, United States of America

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

Reference6 articles.

1. ISO 15197:2013 In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: International Organization for Standardization, 2013.

2. CLSI POCT12-A3 point-of-care blood glucose testing in acute and chronic care facilities; approved guideline, 3rd ed. Wayne, PA: CLSI, 2013.

3. Krouwer JS. Recommendation to treat continuous variable errors like attribute errors. Clin Chem Lab Med 2006;44:797–8.16776622

4. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000;23:1143–8.

5. Assumes that patients who take insulin test 3 times per day – FDA public meeting clinical accuracy requirements for point of care blood glucose meters March 16, 2010. Available from: http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM208598.pdf. Accessed on 23 May, 2013.

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