DEN200052 is an FDA 510(k) submission for the KidneyIntelX.dkd. This device is classified as a Prognostic Test For Assessment Of Chronic Kidney Disease Progression (Class II - Special Controls, product code QWZ).
Submitted by Renalytix Ai, Inc. (New York, US). The FDA issued a Not Cleared (DENG) decision on June 29, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1223. 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..
| 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 | - |
| Product Code | QWZ - Prognostic Test For Assessment Of Chronic Kidney Disease Progression |
| Device Class | Class II - 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. |