KidneyIntelX.dkd

DEN200052

Renalytix AI, Inc. · granted 2023-06-29 · product code QWZ · Clinical Chemistry

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“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 Alc (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)).”
Algorithmartificial intelligence derived algorithm, machine learning (Random Forest)
source quote (p.4)
“A software with an artificial intelligence derived algorithm provides a risk assessment score by combining the biomarker results from the assay (TNFR-1, TNFR-2, and KIM-1) and a set of clinical data, which are provided by a patient's physician via a test requisition form (urine albumin creatinine ratio [uACR], hemoglobin Alc [HbAlc], and Blood Urea Nitrogen [BUN]). The KidneyIntelX.dkd algorithm was modeled using machine learning (Random Forest) to identify and analyze risk factors for kidney disease progression.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=657 patients · 10 site(s)

endpoints: 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; sustained decrease in eGFR ≥ 40% or end-stage kidney disease (sustained eGFR <15 ml/min/1.73m²), within a defined 5-year time frame

standards: CLSI EP05-A3, CLSI EP15-A3, CLSI EP17-A2, CLSI EP07, CLSI EP37, CLSI EP28-A3c, CLSI EP19, CLSI EP25-A

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Clinical Chemistry panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN200052