Acon On Call Extra (v1)
Device Name:
On Call Extra
Manufacturer:
Acon Laboratories Inc., 10125 Mesa Rim Road, San Diego, CA 92121, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger, Palm and Forearm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Acon On Call Extra (v1) 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, palm or forearm.. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Acon On Call Extra (v1), to measure blood glucose, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. However, it was also assessed in another study, but the results have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG TÜV SÜD (DE) General use Unpublished internal data
Validation Publications:

Wolde M, Tarekegn G, Kebede T. Comparative Evaluations of Randomly Selected Four Point-of-Care Glucometer Devices in Addis Ababa, Ethiopia. J Diabetes Sci Technol. 2018 May;12(3):673-9. Epub: 2018 Jan 17. doi: 10.1177/1932296817751747. PMID: 29338325.

15197:2013 - Fail General population

15197:2003 - Fail General population