Page 40 - Glucose Monitoring Devices

36 CHAPTER 2 Analytical performance of SMBG systems

Analytical performance according to FDA
In the United States, the FDA oversees and regulates SMBG systems and blood
glucose monitoring test systems for prescription POC use. FDA regulates these
for all phases of market release: premarket notification for market approval,
manufacturing and performance standards, and postmarketing surveillance. Before
2014, the FDA utilized the ISO 15197:2003 standard for approving glucose meters
in the United States. The FDA introduced draft guidance in 2014 and later finalized
this guidance in 2016, implementing its own standard for BGMs for self-monitoring
that was similar to the ISO 15197:2013. Similar to its modern ISO counterpart, the
2016 FDA guidelines require 95% of measurements to fall within 15% of the refer-
ence BG concentration for BG values 100 mg/dL. However, the FDA also requires
this same level of performance ( 15%) for BG values across the entire range, as
opposed to the more forgiving ISO 2013 criteria of an absolute amount of
15 mg/dL for BG values < 100 mg/dL. It is important to note that the FDA criteria
are especially stringent for the severe hypoglycemic range. For example, 15% of
54 mg/dL only allows for a variance of 8 mg/dL. The accuracy requirements are
unchanged in the latest 2018 draft guidance. A summary of the various analytical
accuracy requirements are found in Table 2.1.
Similar to ISO 15197:2013, the latest 2016 and 2018 FDA guidelines require
daily precision testing over 10 days. The 2016 guidance requires that a minimum
of three test strip lots be scrutinized, but the 2018 draft guidance proposes a
reduction to only two test strip lots.

Table 2.1 International and food and drug administration analytical
accuracy requirements for blood glucose monitors for self-monitoring.
Accuracy standard Minimum accuracy requirements
ISO 15197 2013 95% of glucose values must be within 15 mg/dL
of reference for values <75 mg/dL or within 20%
of reference for values 75 mg/dL
ISO 15197 2016 95% of glucose values must be within 15 mg/dL
of reference for values <100 mg/dL or within 15%
of reference for values 100 mg/dL
FDA 2016 for over-the-counter 95% of glucose values must be within 15% of
BGMs (FDA 2016) reference, and 99% of glucose values must be
within 20% of reference
FDA 2018 Draft Guidance for over- Same as FDA 2016
the-counter BGMs (FDA 2018)