Clinical Chemistry · De Novo · 2023
KidneyIntelX.dkd
Renalytix AI, Inc.. Granted by FDA on 29 June 2023 under submission DEN200052, product code QWZ (prognostic test for assessment of chronic kidney disease progression). What FDA's record says, in FDA's words.
Device record · DEN200052
- Device. KidneyIntelX.dkdDEVICE
- Company. Renalytix AI, Inc.COMPANY
- Decision. 29 June 2023, De NovoDECISION
- Panel. Clinical ChemistryPANEL
- Product code. QWZ, Prognostic Test For Assessment Of Chronic Kidney Disease ProgressionCODE
- Regulation. 21 CFR 862.1223, Class IIREG
- Source. FDA database entry · decision document (19 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
A Indication(s) for Use: 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 Alc (HbAlc) 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. B Special Conditions for Use Statement(s): Rx - For Prescription Use Only KidneyIntelX.dkd is for In-Vitro Diagnostic Use: Only performed at Renalytix clinical laboratory. KidneyIntelX.dkd is not intended as a screening or stand-alone diagnostic test. KidneyIntelX.dkd is not for use in the diagnosing or staging of diabetic kidney disease. KidneyIntelX.dkd test results are intended […]
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsprescription use
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QWZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
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