De Novo · Granted
GrantedKidneyIntelX.dkd
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renalytix Ai, Inc. · QWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression
Granted on Jun 29, 2023 as a new device type through De Novo after a 1,037-day review.
- Decided
- Jun 29, 2023
- Review
- 1,037 days
- Class
- Class II
- Product code
- QWZ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QWZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QWZ devicesQWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QWZ
Too few QWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QWZ
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QWZ
No MAUDE report names QWZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 3 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
KidneyIntelX.dkd is for in-vitro diagnostic use for the determination of a KidneyIntelX.dkd Level using an algorithm to combine clinical variables (blood urea nitrogen (BUN), hemoglobin A1c (HbA1c) and urine albumin creatinine ratio (uACR)) and the quantitative measurements of tumor necrosis factor receptor-1 (TNFR-1), tumor necrosis factor receptor-2 (TNFR-2) and kidney injury molecule-1 (KIM-1) in human plasma employing a Meso Sector S 600…
Read the full statement (163 words)
KidneyIntelX.dkd is for in-vitro diagnostic use for the determination of a KidneyIntelX.dkd Level using an algorithm to combine clinical variables (blood urea nitrogen (BUN), hemoglobin A1c (HbA1c) and urine albumin creatinine ratio (uACR)) and the quantitative measurements of tumor necrosis factor receptor-1 (TNFR-1), tumor necrosis factor receptor-2 (TNFR-2) and kidney injury molecule-1 (KIM-1) in human plasma employing a Meso Sector S 600 electrochemiluminescence immunoassay. It is indicated for use as an aid in assessment of the risk of progressive decline in kidney function (sustained decrease in eGFR greater than or equal to 40% lasting more than 3 months) within a period of up to 5 years following KidneyIntelX.dkd Level measurement in adult patients with type 2 diabetes and existing chronic kidney disease (defined for the purposes of this device as patients with an estimated glomerular filtration rate of 30-59 ml/min/1.73m² or eGFR ≥ 60 ml/min/1.73m² with albuminuria (uACR ≥ 30 mg/g)).
KidneyIntelX.dkd is not intended for screening or as a stand-alone diagnostic test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200052 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200052: KidneyIntelX.dkd.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200052
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026