NEW YORK – RenalytixAI on Thursday announced the submission of a 510(k) application to the US Food and Drug Administration for its KidneyIntelX assay.
The London-based firm is seeking FDA clearance for use of KidneyIntelX, in combination with clinical evaluation, as an aid to further determine the risk of progressive decline in kidney function for up to five years in patients over the age of 21 with type 2 diabetes and chronic kidney disease (CKD).
KidneyIntelX applies machine-learning algorithms to assess predictive blood-based biomarkers — including sTNFR1, sTNFR2, and KIM1 — and electronic health record information to identify progressive kidney disease.
RenalytixAI said that performance data in the submission is based on a multi-center validation study of more than 1,100 patients indicating that the assay accurately identifies patients in early CKD stages 1, 2, and 3, who are at the highest risk of progressive decline in kidney function or kidney failure.
RenalytixAI previously announced in May that the FDA granted Breakthrough Device designation for the artificial intelligence-enabled in vitro diagnostic for kidney disease.
The firm also noted that the FDA filing builds on its regulatory and commercial plans, which included prior approval from the New York State Department of Health in June.