21 CFR 862.1223 — Prognostic Test For Assessment Of Chronic Kidney Disease Progression

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1223

Identification

KidneyIntelX.dkd is an in-vitro diagnostic test that uses an algorithm to combine clinical variables (blood urea nitrogen (BUN), hemoglobin A1c (HbA1c), and urine albumin creatinine ratio (uACR)) and quantitative measurements of three circulating biomarkers (tumor necrosis factor receptor-1 (TNFR-1), tumor necrosis factor receptor-2 (TNFR-2), and kidney injury molecule-1 (KIM-1)) in human plasma. It is indicated as an aid in the assessment of the risk of progressive decline in kidney function (sustained decrease in eGFR ≥ 40% lasting more than 3 months) within a period of up to 5 years in adult patients with type 2 diabetes and existing chronic kidney disease.

Classification Rationale

Class II with special controls. The device is classified under 21 CFR 862.1223 as a prognostic test for assessment of chronic kidney disease progression.

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