QWZ · Class II · 21 CFR 862.1223

FDA Product Code QWZ: 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.

Leading manufacturers include Renalytix Ai, Inc..

1
Total
0
Cleared
1037d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prognostic Test For Assessment Of Chronic Kidney Disease Progression Devices (Product Code QWZ)

1 devices
1–1 of 1
Not Cleared Jun 29, 2023
KidneyIntelX.dkd
DEN200052
Renalytix Ai, Inc.
Chemistry · 1037d

About Product Code QWZ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWZ since 2023, with 0 receiving FDA clearance (average review time: 1037 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QWZ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →