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Handok Barozen H Plus
Device Name:
Barozen H Plus
Manufacturer:
Handok Inc., Handok Tower, 132 Teheran-ro, Gangnam-gu, Seoul 06235, REPUBLIC of KOREA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for laboratory use only
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Handok Barozen H Plus 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 laboratory use only.
Assessment:
The technology used in the Handok Barozen H Plus, to measure blood glucose, has been assessed, in a specific population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
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.
BG MDR Criteria Adults Validation with amended protocol - may require further study
Validation Publications:

Cho J, Ahn S, Yim J, Cheon Y, Jeong SH, Lee SG, Kim JH. Influence of Vitamin C and Maltose on the Accuracy of Three Models of Glucose Meters. Ann Lab Med. 2016 May;36(3):271-4. doi: 10.3343/alm.2016.36.3.271. PMID: 26915620. Available from: PMC4773272. Letter.

15197:2013 Validation with maltose interference (Note: No significant intereference at any maltose concentration was noted.)

15197:2013 Validation with high Vit C (30 mg/dl) concentrations (Note: Non-significant positive interference was observed for the Barozen H.)