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Industry Standards for Accuracy

FDA recognizes National Committee for Clinical Laboratory Standards1

ADA goal: +/- 10% at ranges 30-400mg/dL2

Clinically acceptable is +/- 15% of the standard laboratory value3

“Most patients with some formal training can obtain results within 20% of the lab reference”4

Most meter result errors are user related5

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1 NCCLS Method Comparison and Bias Estimation Using Patient Samples

       EP9-A Vol. 15 No. 17

     2     ADA Consensus Statement.  Diabetes Care 1987; 1:95-99

      3-5 Ibid.

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