Laboratory_medicine
KidneyIntelX.dkd
Renalytix AI, Inc.
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.
FDA Submission Metadata
- Submission number
- DEN200052
- Decision date
- June 2023
- FDA panel
- Clinical Chemistry
- Product code
- QWZ
- Clinical task (npj)
- predictive
- Data modality (npj)
- Omics
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.