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i-Sens CareSens H Beat

Device Name:CareSens H Beat
Manufacturer:Sole: 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 H Beat is a clinically validated and 2-star blood glucose meter. Measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:

The technology used in the i-Sens CareSens H Beat, 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.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Kim HN, Moon KC, Yoon SY. Performance evaluation of three i-SENS glucometers using arterial blood samples compared with the YSI 2300 Glucose Analyzer. J Clin Lab Anal. 2020 Aug;34(8):e23356. Epub: 2020 May 19. doi: 101002/jcla23356. PMID: 32430994. Available from: PMC7439437.

15197:2013 - Pass General population (Note: Modified protocol: Fewer samples with low and high blood glucose concentrations than recommended.)