FDA 510K for Neuroleptic Drugs Radioreceptor Assay Test System
A Neuroleptic Drugs Radioreceptor Assay Test System is a device that measures the amount of dopamine receptor-blocking neuroleptic drugs in blood. It can be used to measure the levels of neuroleptic drugs in serum or plasma
Intended Use of Neuroleptic Drugs Radioreceptor Assay Test System
A Neuroleptic Drugs Radioreceptor Assay Test System is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.
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 Neuroleptic Drugs Radioreceptor Assay Test System
FDA 510K for Neuroleptic Drugs Radioreceptor Assay Test System Device Code and Regulation Number
| S.No | Product Code | Device | Regulation Description | Regulation Number | Class |
|
1 |
Enzyme Immunoassay, Carbamazepine | Neuroleptic Drugs Radioreceptor Assay Test System |
862.3645 |
2 |
Enzyme Immunoassay, Carbamazepine
Intended use:
In vitro test for the quantitative determination of carbamazepine in serum and plasma. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy
Device Description:
The assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. It is a homogeneous microparticle agglutination immunoassay based on the kinetic interaction of microparticles in solution (KIMS). Biotinylated drug hapten serves as the binding partner to anti-carbamazepine antibody and streptavidin-coated latex beads. A competitive reaction to a limited amount of specific anti-carbamazepine antibody takes place between the hapten and free carbamazepine in the sample. A decrease in the apparent signal produced by microparticle agglutination is proportional to the amount of drug present in the sample.
Performance Testing (Analytical) for Neuroleptic Drugs Radioreceptor Assay Test System
- Detection Limit: LoB, LoD and LoQ
- Precision
- Linearity
- Matrix Comparison
- Interferences
Clinical Testing
No Guidance available for 510k submission