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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
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.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
MDR CriteriaAdultsValidation 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.)