Tuesday, March 31, 2020

Tuesday, March 31, 2020

FDA approves new at home smartphone urinalysis test kit

The FDA recently approved a home urinalysis test kit comparable to clinical testing.

The Dip.io urinalysis test was originally developed by the Israeli-based company Healthy.io and received FDA 510(k) clearance. The test is for the semi-quantitative detection of glucose, blood, pH, protein, and specific gravity as well as the qualitative detection of nitrite via mandated in vitro diagnostic use only, according to a SEDD summary.

The Dip.io testing kit received both CE marking and an International Organization for Standardization, a certification mark that indicates health, safety, and environmental protection standards for products sold within the European Economic Area—making it commercially available in the EU and the U.K.

The kit is comprised of an individually wrapped urine receptacle, Mission urinalysis reagent strip, color-board and an innovative smartphone app with backend cloud-based server, claiming usability across age groups from their late teems into their 80s.

Organizations in this Story

US Food and Drug Administration

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