GHA NIGA01
Device Name:
NIGA01
Manufacturer:

OBL: Global Health Ark Medical Technology (Beijing) Co. Ltd., 606 Building C, Huilongsen Second Garden, 18 Xihuannan Road, Yizhuang, Beijing, CHINA.

Other: Bobang Fangzhou Medical. Technology (Beijing) Co. Ltd., Suite 808, Building 2, Runshi Center, 16 Tianze Road, Beijing 100012, CHINA.

Measuring functions:
Blood glucose
Primary Client Use:
Developed as a research version only - Never sold commercially
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Not made available
Description:
The GHA NIGA01 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 use only as a reasearch version.
Assessment:
The technology used in the GHA NIGA01, to measure blood glucose, has been assessed, in a general population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★ Recommendation Recent clinical validation; recent protocol
Validation Publications:

Li A, Li X, Xu Y, Wu C, Geng Z, Zhang J, Wang X, Li Y, Li H, Guo X, Tang F. Evaluating the Clinical Accuracy of a Non-invasive Single-Fasting-Calibration Glucometer in Patients with Diabetes: A Multicentre Study. Diabetes Ther. 2023 Jun;14(6):989-1004. Epub: 2023 Apr 27. doi: 10.1007/s13300-023-01402-8. PMID: 37103775. Available from: PMC10203088.

15197:2013 General population

The metabolic heat conformation GHA NIGA01 demonstrated generally high stability and accuracy. The calculation model needs to be developed further to address different diabetes subtypes, levels of insulin resistance and insulin secretion capacity.

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