The Fora Premium V10 (TD-4124) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.

While the technology used in the Fora Premium V10 (TD-4124), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified. It also appears to be very similar to another device by the same manufacturer, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BG	Institute of Health Economics (CA)	General use	No evidence provided