The updated FDA POCT glucose meter performance standard has a big problem

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As readers may be aware, I have ranted against glucose meter standards for some time. Although the standards have many flaws, the most egregious one is the failure to specify 100% of the results. For POCT glucose meters, the CLSI standard C30-A2 (2003) adopted the ISO glucose meter standard 15197, which accounts for 95% of the results.

In 2013, CLSI updated its standard, now called POCT 12-A3 to include 98% of the results.

In 2014, FDA issued a draft POCT glucose meter guidance which covers 100% of the results.

But, now FDA has updated its POCT glucose meter guidance to cover only 98% of the results.

There’s no reason to allow 2% of the results to be unspecified – I don’t know why the FDA did this.

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One Response to The updated FDA POCT glucose meter performance standard has a big problem

  1. […] I alerted readers to the fact that the updated FDA POCT glucose meter standard no longer specifies 100% of […]

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