Prognostic Test For Assessment Of Chronic Kidney Disease Progression
The prognostic test for assessment of chronic kidney disease progression (product code QWZ) is a Class 2 Clinical Chemistry in vitro diagnostic device (regulation 862.1223) intended to measure one or more analytes from human samples as an aid in assessing the risk for progression of chronic kidney disease. Requiring 510(k) clearance, it is not intended for diagnosis of any disease, serial monitoring of kidney disease progression, or monitoring the effect of any therapeutic product. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWZ
- Device Class
- FDA class 2
- Regulation Number
- 862.1223
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200052 | KidneyIntelX.dkd | Jun 29, 2023 | Unknown | Renalytix Ai, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.