US FDA Clearance Approval for PixoTest POCT Analyzer and PixoTest A1c Test Kit

iXensor Co., Ltd, is the leading digital mobile health company that developed the PixoTech platform to analyze colorimetric assays using smartphone cameras. iXensor announces that its PixoTest POCT Analyzer and PixoTest A1c Test Kit has received the U.S. Food and Drug Administration 510(k) clearance for clinical laboratory and Point-of-Care.

“The small size, lightweight, and short operating time of The PixoTest POCT System makes highly portable, convenient to use, with small sample size (5μl) of capillary and venous blood, while demonstrating great performance on accuracy and linearity.”(1)

Currently, PixoTest POCT has FDA clearance, CE, and IFCC certification and has demonstrated its medical value in the field of telemedicine in remote areas (2). iXensor expects to obtain CLIA waiver in 2020 and help more people access quality primary healthcare.

(1)
Reading the full clinical study >>>

https://link.springer.com/epdf/10.1007/s40846-019-00488-5?author_access_token=56j0ouUJ-WPPK3dXuiNVjve4RwlQNchNByi7wbcMAY6kmR5eH9xaeu2abp-vOjrtQOCpLhpD2Fw3Itt3kIEQ3_3WsjG5lSA8nrBEsm7dyL4WO3X4TOtU8BK2g2w5wihKbVJvFQGMRmztldEwIFY0Gg==

(2) https://www.ixensor.com/ixensor_web/curafa/

 

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