BTNX Rapid Response (04GLU-67)

Device Name:

Rapid Response

Device Model:

04GLU-67

Manufacturer:

BTNX Inc., Unit 23, 570 Hood Road, Markham, ON L3R 4G7, CANADA.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The BTNX Rapid Response (04GLU-67) 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 taken from the finger. It is intended for self-measurement and home use.

Assessment:

While the technology used in the BTNX Rapid Response (04GLU-67), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	While a clinical validation is claimed, it cannot be checked properly.
BG	Institute of Health Economics (CA)	General use	No evidence provided