(1037 days)
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 A 1c (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.
KidneyIntelX.dkd provides the KidneyIntelX.dkd level, generated by the KidneyIntelX.dkd algorithm. The algorithm includes inputs from clinical data collected on the patient as well as component analytes measured directly by KidneyIntelX.dkd.
The three component analytes measured by KidneyIntelX.dkd directly are quantitated via a multiplex electrochemiluminescence technology for the in vitro quantitative determination the concentration of three circulating biomarkers in human EDTA plasma:
- i) soluble Tumor Necrosis Factor Receptor 1 (TNFR-1),
- ii) soluble Tumor Necrosis Factor Receptor 2 (TNFR-2),
- iii) and Kidney Injury Molecule (KIM)-1.
The three measured components of the KidneyIntelX.dkd level are measured using the MESO SECTOR® S 600 instrument, by trained laboratory personnel using the assay components that includes the KidneyIntelX 96-well plate, the detection antibody, calibrator, and controls along with the Meso Scale Diagnostics diluents, blocker, wash buffer and read buffer.
A sandwich immunoassay is used to measure KIM-1, TNFR-1, and TNFR-2. The plate wells are precoated with goat polyclonal antibodies to KIM-1, and mouse monoclonal antibodies specific to TNFR-1 and TNFR-2. After treating the wells with a blocking solution, the specimens and controls are incubated in the wells then washed. The analytes are quantified via electrochemiluminescence, with secondary detection antibodies (goat polyclonal antibodies to KIM-1, and mouse monoclonal antibodies specific to TNFR-1 and TNFR-2) covalently linked to electrochemiluminescent labels. The MESO SECTOR® S 600A instrument measures the light emitted via charged-coupled device (CCD) camera.
A software with an artificial intelligence derived algorithm provides a risk assessment score by combining the biomarker results from the assay (TNFR-1, TNFR-2, and KIM-1) and a set of clinical data, which are provided by a patient's physician via a test requisition form (urine albumin creatinine ratio [uACR], hemoglobin A1c [HbA1c], and Blood Urea Nitrogen [BUN]). The algorithm generates a risk level (Low, Moderate, or High) for progressive decline in kidney function, defined as sustained decrease (
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Clinical Performance: Ability to predict progressive decline in kidney function (sustained decrease in eGFR ≥ 40% lasting > 3 months) or reaching end stage kidney disease (sustained eGFR ±10% change for KIM-1, TNFR-1, TNFR-2 (Total Protein, Rheumatoid Factor). | Worst-case scenario interference (+/- 10%) used for simulations. Specific limitations added regarding high RF or total protein. Criteria: >=5% of patient simulations not matching original category considered affected. | |
| Assay Reportable Range: Established measuring intervals for KIM-1, TNFR-1, TNFR-2. | KIM-1: 12 pg/mL to 3,915 pg/mL | |
| TNFR-1: 1,057 pg/mL to 14,322 pg/mL | ||
| TNFR-2: 4,270 pg/mL to 43,291 pg/mL | Data supports these intervals considering LoB/LoD/LoQ, linearity, and precision. | |
| Traceability: KIM-1, TNFR-1, TNFR-2 methodologies. | Traceable to internal standards. | |
| Stability: KIM-1, TNFR-1, TNFR-2 in samples for shipping. | Stable for 3 days at up to 37℃. | Consistent with handling instructions for shipping to the lab. |
| Detection Limit (LoB, LoD, LoQ): For KIM-1, TNFR-1, TNFR-2. | LoB, LoD determined per CLSI EP17-A2. LoQ defined as lowest concentration with total within-laboratory precision of %CV60, Black/African American vs Non-Black/African American). | Shown via Kaplan-Meier curves and estimated 5-year rates. |
| Lack of Diagnosis/Staging: Not intended for diagnosing or staging DKD. | Labeling explicitly states this. | Part of the "Special Conditions for Use Statement(s)". |
| Rx - For Prescription Use Only: Restriction on use. | Labeling explicitly states this. | Part of the "Special Conditions for Use Statement(s)". |
Study Information:
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A table of acceptance criteria and the reported device performance: Included above.
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Sample sized used for the test set and the data provenance:
- Sample Size: N = 657 patients.
- Data Provenance: Retrospective analysis of biobanked samples. Sourced from a single biorepository site that collected from 10 clinical sites in the United States (implied by references to US population and demographics like "American Indian/Alaskan Native", "Black/African American", "White", "Hispanic"). The study included up to 5 years of data per sample.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The ground truth ("progressive decline in kidney function" and "end-stage kidney disease") is defined by clinical outcomes (e.g., sustained decrease in eGFR, eGFR
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