Trividia TRUE Focus

Device Name:

TRUE Focus

Manufacturer:

Distributer: Trividia Health Inc. (Formerly Nipro/HDI [Home Diagnostics Inc.]), 2400 NW 55th Court, Fort Lauderdale, FL 33309, UNITED STATES.

Other: Nipro Corporation, 3-9-3 Honjo-Nishi, Kita-Ku, Osaka 531-8510, JAPAN.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger and general Alternative Site Testing

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

United States

Description:

The Trividia TRUE Focus 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 self-measurement and home use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Trividia TRUE Focus to measure blood glucose.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has not been clinically validated.