Table 1.
Representative international standards for assessment of acceptable performance
| Regulatory Organism | Country | Device | Standard | Year | Ref. |
|---|---|---|---|---|---|
| Food and Drug Administration | USA | POCTs | FDA-2013-D-1445 | 2020 | 60 |
| Food and Drug Administration | USA | OTC BGMS | FDA-2013-D-1446 | 2020 | 61 |
| International Standard Organization | 165 countries | BGMS | ISO 15197 | 2015 | 62-64 |
| Clinical and Laboratory Standards Institute | >50 countries | POCTs | POCT12-A3 | 2018 | 62 |
POCT, point-of-care test; OCT, over-the-counter; BGMS, blood glucose monitoring test systems; FDA, food and drug administration; ISO, international standard organization.