Acute Kidney Injury Test System and 510k Process
Acute kidney injury (AKI) occurs when the kidneys suddenly become unable to filter waste products from the blood. Diagnosing AKI involves a combination of clinical signs, lab tests, and monitoring.
Intended Use of Acute Kidney Injury Test System
An acute kidney injury test system is a device that is intended to measure one or more analytes in human samples as an aid in the assessment of a patient’s risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Acute Kidney Injury Test System
Acute Kidney Injury Test System Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | PIG | Acute Kidney Injury Test System | Acute Kidney Injury Test System | 862.1220 | 2 |
Acute Kidney Injury Test System (PIG)
Intended Use: Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
Device Description: An Acute Kidney Injury (AKI) test system is a diagnostic platform used to detect and assess the risk of kidney injury in patients, particularly in critical care settings. These systems detect specific biomarkers, such as NGAL, TIMP-2, and IGFBP-7, in biological samples like urine or blood. Using specialized clinical analyzers and immunoassay technology, the system provides quantitative results that help clinicians identify early signs of AKI, enabling timely intervention. The systems include reagents, sample collection tools, and data interpretation software, ensuring accurate and automated testing with minimal manual intervention. Regulated by health authorities, these systems offer high sensitivity and specificity, allowing for reliable results in patient care. Identifying AKI early, helps reduce kidney damage and improve outcomes.
Performance Testing (Analytical) for Acute Kidney Injury Test System
- Stability Studies
- Precision/Reproducibility
- Linearity/assay reportable range
- Detection limit
- Analytical Specificity / Cross-Reactivity
- Traceability (controls, calibrators, or method)
- Analytical Sensitivity
- Interference
- Precision /reproducibility
- High-Dose Hook Effect
- Specimen Stability
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Applicable for 510k submission and IVDR CE Marking