Not Cleared Direct

DEN200052 - KidneyIntelX.dkd (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200052 · Renalytix Ai, Inc. · Chemistry device
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Jun 2023
Decision
1037d
Days
Class 2
Risk

DEN200052 is an FDA 510(k) submission (not cleared) for the KidneyIntelX.dkd. Classified as Prognostic Test For Assessment Of Chronic Kidney Disease Progression (product code QWZ), Class II - Special Controls.

Submitted by Renalytix Ai, Inc. (New York, US). The FDA issued a Not Cleared (DENG) decision on June 29, 2023 after a review of 1037 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1223 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 1037 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Renalytix Ai, Inc. devices

Submission Details

510(k) Number DEN200052 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 26, 2020
Decision Date June 29, 2023
Days to Decision 1037 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
949d slower than avg
Panel avg: 88d · This submission: 1037d
Pathway characteristics

Device Classification

Product Code QWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1223
Definition A Prognostic Test For Assessment Of Chronic Kidney Disease Progression Is An In Vitro Diagnostic Device Intended To Measure One Or More Analytes Obtained From Human Samples As An Aid In Assessing The Risk For Progression Of Chronic Kidney Disease. This Device Is Not Intended For Diagnosis Of Any Disease, For Serial Monitoring Of Kidney Disease Progression, Or For Monitoring The Effect Of Any Therapeutic Product.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.