FDA 510K for Ammonia Test System
Tests measure the concentration of ammonia in the blood and are commonly used to diagnose conditions that affect the liver, brain, and other organs. Elevated levels of ammonia in the blood can indicate liver disease, such as cirrhosis or liver failure, or metabolic disorders like urea cycle disorders. Ammonia buildup in the blood can be toxic, especially to the brain, leading to confusion, lethargy, or even coma in severe cases.
Intended Use of Ammonia Test System
An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye’s syndrome.
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 Ammonia Test System
Ammonia Test System Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | JIF | Enzymatic Method, Ammonia | Ammonia Test System | 862.1065 | 2 |
Enzymatic method, ammonia (JIF)
Intended Use: The Ammonia II assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye’s syndrome.
Device description: The Ammonia II assay is an enzymatic method, with glutamate dehydrogenase. Glutamate dehydrogenase (GLDH) catalyzes the reductive amination of 2‑oxoglutarate with NH4+ and NADPH to form glutamate and NADP+. The concentration of the NADP+ formed is directly proportional to the ammonia concentration. It is determined by measuring the decrease in absorbance
Performance Testing (Analytical) for Ammonia Test System
- Linearity/assay reportable range
- Precision/Reproducibility
- Sensitivity
- Analytical specificity
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Not Applicable for 510k submission and IVDR CE Marking