Devices · Renalytix AI, Inc.

KidneyIntelX.dkd

Renalytix AI, Inc. is listed for KidneyIntelX.dkd (DEN200052). The FDA list gives June 29, 2023 as the date of the final decision. The lead panel is Clinical Chemistry, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QWZ as “Prognostic Test For Assessment Of Chronic Kidney Disease Progression”: 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200052

Official FDA database record

Date of final decision

June 29, 2023

Company on the FDA list

Renalytix AI, Inc.

Lead panel

Clinical Chemistry

Primary product code

QWZ

openFDA device name for the code

Prognostic Test For Assessment Of Chronic Kidney Disease Progression

Device class

2

Regulation number

862.1223

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned