Product code QWZ— Clinical Chemistry
KidneyIntelX.dkd
- Classification name
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- Device class
- Class 2
- Regulation
- 21 CFR 862.1223
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QWZ
FDA has cleared device under product code QWZ, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QWZ
Recent clearances under product code QWZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.