The Fora Premium V10 BLE (TD-4124B) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. 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.

There appears to be no peer-reviewed clinical validation information available on the technology used in the Fora Premium V10 BLE (TD-4124B) to measure blood glucose. However, this device appears to be very similar to another device by the same manufacturer. At least one validation needs to be published and 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	Not recommended	This device has not been shown to have been clinically validated.