VivaChek Ino (VGM01)
Device Name:
Ino
Device Model:
VGM01
Manufacturer:
Distributer: VivaChek Laboratories Inc., Suite 200, 913 N Market Street, Wilmington, DE 19801, UNITED STATES.
Other: VivaChek Biotech (Hangzhou) Co. Ltd., Level 2, Block 2, 146 East Chaofeng Road, 311100 Hangzhou, CHINA.
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 VivaChek Ino (VGM01) is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the VivaChek Ino (VGM01), to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |
| BG | MDR Criteria | Self-measurement | Published evidence |
Validation Publications:
Hehmke B, Berg S, Salzsieder E. Accuracy Evaluation of a CE-Marked Glucometer System for Self-Monitoring of Blood Glucose With Three Reagent Lots Following ISO 15197:2013. J Diabetes Sci Technol. 2017 May;11(3):635-6. Epub: 2016 Oct 4. doi: 10.1177/1932296816670401. PMID: 27707915. Available from: PMC5505413.
15197:2013 - Pass General population