A creatinine test system refers to the medical equipment or methodology used to measure the levels of creatinine in a patient’s blood or urine. Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. The creatinine test is commonly used to assess kidney function, as the kidneys filter creatinine from the blood and excrete it in urine. Elevated creatinine levels may indicate impaired kidney function or other kidney-related issues

Intended Use of Creatinine Test System

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes

Intended Use:

The system is intended for use by healthcare professionals in diagnosing and monitoring renal diseases and dialysis treatments through quantitative measurement of creatinine levels in blood. It is not suitable for neonates.

Device Description:

system is a portable, battery-powered device designed to measure creatinine levels in whole blood samples. It includes a hand-held meter, electrochemical test strips, control and linearity solutions, and a charging station. The meter analyzes the sample in 30 seconds and stores patient and test data, with a user-friendly color LCD interface. The test strips contain enzymes that react with the blood sample and are drawn into the strip via capillary action. The control and linearity solutions, available at various levels, are used to verify system performance. The charging station recharges the meter’s battery and has an additional slot for an extra battery.

Alkaline Picrate, Colorimetry, Creatinine

Intended Use:

The assay is used for the quantitation of creatinine in human serum, plasma, or urine. The assay is to be used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes

Device Description:

The measurement of creatinine concentration using alkaline picrate and colorimetry relies on the Jaffe reaction, where creatinine in an alkaline solution reacts with picric acid to form a yellow-orange complex. The intensity of the color produced is proportional to the creatinine concentration. A colorimeter or spectrophotometer is used to measure the absorbance of light at a specific wavelength (usually 490 nm), with the amount of light absorbed being directly related to the concentration of creatinine. A calibration curve, created from known creatinine standards, allows for the determination of the creatinine concentration in the sample. This method is commonly used in clinical diagnostics to assess kidney function.

Enzymatic Method, Creatinine

Intended Use:

The assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin and dipotassium EDTA), and urine. The measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Device Description:

The enzymatic method for measuring creatinine involves using specific enzymes to convert creatinine into measurable products, typically ammonia or formaldehyde. This method is more specific and accurate than traditional methods, reducing interference from other substances. The process involves enzymes like creatininase, creatine ammonia lyase, and sarcosine oxidase to break down creatinine in a controlled reaction. While the method offers high precision, it can be more expensive and complex compared to older techniques. It is widely used in clinical settings for reliable creatinine measurements.

Test, Cystatin C

Intended Use:

The assay is for the in vitro diagnostic use in the quantitative determination of cystatin C in human serum and plasma (lithium heparin, potassium EDTA. Measurement of cystatin C aids in the diagnosis and treatment of renal disease

Device Description:

Cystatin C testing device is a medical tool used to measure the concentration of Cystatin C in blood samples to assess kidney function. It typically includes components for sample collection, reagents that react with Cystatin C, and a detection method such as immunoassay or turbidimetry, which provides a measurable signal.

Performance Testing (Analytical) for Creatinine Test System  

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Assay cut-off.
• Analytical Specificity (Cross Reactivity)

Clinical Testing:

No Guidance available for 510k submission