Abbott FreeStyle Mini

Device Name:

Freestyle Mini

Manufacturer:

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

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 Abbott FreeStyle Mini is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Abbott FreeStyle Mini, to measure blood glucose, has been assessed, in a specific population, according to a non-standard protocol.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications:

de Mol P, Krabbe HG, de Vries ST, Fokkert MJ, Dikkeschei BD, Rienks R, Bilo KM, Bilo HJ. Accuracy of handheld blood glucose meters at high altitude. PLoS One. 2010 Nov 12;5(11):e15485. doi: 10.1371/journal.pone.0015485. PMID: 21103399.

Ad Hoc protocol - Fail High Altitude (Note: Simulated altitude in hypobarbic chamber)