FDA 510K for Urea Nitrogen Test System
The Urea Nitrogen Test System is an in vitro diagnostic device designed to measure the concentration of urea nitrogen (BUN) in human blood. Urea nitrogen is a crucial marker for evaluating kidney function, as abnormal levels can signal a range of health issues, including kidney disease, dehydration, and liver dysfunction. This test helps healthcare providers assess and monitor patients’ renal health and guides appropriate treatment decisions.
Intended Use of Urea Nitrogen Test System
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
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 Urea Nitrogen Test System
FDA 510K for Urea Nitrogen Test System Device Code and Regulation Number
| S.
No. |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | Urea Nitrogen Test System | 862.1770 | 2 |
Urea Nitrogen Test System
Intended Use
The Urea Nitrogen test is used to measure the level of urea nitrogen in human serum, plasma, or urine. This test helps in the diagnosis and treatment of various renal and metabolic conditions, providing important information about kidney and overall metabolic health.
Device Description
The device is a urea nitrogen test system intended to measure urea nitrogen, an end product of nitrogen metabolism, in human whole blood, serum, plasma, and urine. The test operates by applying an enzymatic or chemical reaction to the specimen, in which urea nitrogen is converted, and the resulting change in signal (e.g., colorimetric, enzymatic, electrode/ion-specific, or conductivity measurement) is detected and quantified by the instrument to determine the concentration of urea nitrogen. Results from the urea nitrogen test system are intended to be used in the diagnosis and treatment of certain renal and metabolic diseases.
Performance Testing (Analytical) for Urea Nitrogen Test System
- Precision (Reproducibility and Repeatability)
- Assay range
- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
- Accuracy
- Linearity
- Interfering Endogenous and Exogenous Substances
- Comparison studies
Clinical Testing
No Guidance available for 510k submission