# DEN200052: KidneyIntelX.dkd

- Pathway: De Novo (Direct)
- Applicant: Renalytix Ai, Inc.
- Decided: Jun 29, 2023 after 1,037 days
- Product code: QWZ (Prognostic Test For Assessment Of Chronic Kidney Disease Progression)
- Device class: 2
- Regulation: 21 CFR 862.1223
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
KidneyIntelX.dkd is for in-vitro diagnostic use for the determination of a KidneyIntelX.dkd Level using an algorithm to combine clinical variables (blood urea nitrogen (BUN), hemoglobin A1c (HbA1c) and urine albumin creatinine ratio (uACR)) and the quantitative measurements of tumor necrosis factor receptor-1 (TNFR-1), tumor necrosis factor receptor-2 (TNFR-2) and kidney injury molecule-1 (KIM-1) in human plasma employing a Meso Sector S 600 electrochemiluminescence immunoassay. It is indicated for use as an aid in assessment of the risk of progressive decline in kidney function (sustained decrease in eGFR greater than or equal to 40% lasting more than 3 months) within a period of up to 5 years following KidneyIntelX.dkd Level measurement in adult patients with type 2 diabetes and existing chronic kidney disease (defined for the purposes of this device as patients with an estimated glomerular filtration rate of 30-59 ml/min/1.73m² or eGFR ≥ 60 ml/min/1.73m² with albuminuria (uACR ≥ 30 mg/g)). KidneyIntelX.dkd is not intended for screening or as a stand-alone diagnostic test.

Source page: https://510kreport.com/device/DEN200052
Methodology: https://510kreport.com/methodology