510(k) DEN200052
DEN200052 is an FDA 510(k) premarket notification submitted by Renalytix Ai, Inc. for the device "KidneyIntelX.dkd". The FDA issued a decision of De Novo granted on Jun 29, 2023. The device falls under product code QWZ (Prognostic Test For Assessment Of Chronic Kidney Disease Progression), a Class II device regulated under 21 CFR 862.1223.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Jun 29, 2023
- Date Received
- Aug 26, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- Device Class
- Class II
- Regulation Number
- 862.1223
- Review Panel
- CH
- Submission Type
- 510(k)
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.