FDA product code QWZ: Prognostic Test For Assessment Of Chronic Kidney Disease Progression
QWZ is the FDA product code for prognostic test for assessment of chronic kidney disease progression. It is a Class II device, regulated under 21 CFR 862.1223 and reviewed by the Clinical Chemistry panel. Devices under QWZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 3 recalls for QWZ devices, 3 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prognostic Test For Assessment Of Chronic Kidney Disease Progression |
| Device class | Class II |
| Regulation | 21 CFR 862.1223 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for QWZ devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 3 |
Frequently asked questions
What is FDA product code QWZ?
QWZ is the FDA product code for prognostic test for assessment of chronic kidney disease progression. It is a Class II device, regulated under 21 CFR 862.1223 and reviewed by the Clinical Chemistry panel.
What device class is QWZ?
Class II, regulation 21 CFR 862.1223. Typical premarket route: 510(k).
Have QWZ devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code QWZ
- Run a recall and safety report across every QWZ manufacturer
- Watch product code QWZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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