Abbott FreeStyle Optium H

Device Name:

FreeStyle Optium H

Manufacturer:

Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for both professional use and self-measurement

Measurement Site:

Finger and general Alternative Site Testing

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Abbott FreeStyle Optium H 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.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Abbott FreeStyle Optium H to measure blood glucose.

Recommendations:

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