i-Sens CareSens N Premier
Device Name:
CareSens N Premier
Manufacturer:
i-Sens Inc., 43 Banpo-daero 28-gil, Seocho-gu, Seoul 06646, REPUBLIC of KOREA.
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 i-Sens CareSens N Premier 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 i-Sens CareSens N Premier, 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| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |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:
Pleus S, Jendrike N, Baumstark A, Mende J, Haug C, Freckmann G. Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision. J Diabetes Sci Technol. 2019 Jan;13(1):111-117. Epub: 2018 Oct 5. doi: 10.1177/1932296818804837. PMID: 30286620. Available from: PMC6313280.
15197:2013 - Pass General population