QWZ — Prognostic Test For Assessment Of Chronic Kidney Disease Progression Class II
FDA product code QWZ covers "Prognostic Test For Assessment Of Chronic Kidney Disease Progression", a Class II medical device regulated under 21 CFR 862.1223. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QWZ
- Device Class
- Class II
- Regulation Number
- 862.1223
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200052 | renalytix ai | KidneyIntelX.dkd | June 29, 2023 |