FDA 510K for Tricyclic Antidepressant Drugs Test System
The Tricyclic Antidepressant (TCA) Drugs Test System is a diagnostic device designed to measure the concentration of tricyclic antidepressant drugs (e.g., amitriptyline, nortriptyline, desipramine) in human serum, plasma, or urine. These drugs are used to treat depression, anxiety, and other psychiatric disorders. The test system aids in therapeutic drug monitoring (TDM) to ensure proper dosing, prevent toxicity, and manage overdose risks.
Intended Use of Tricyclic Antidepressant Drugs Test System
A Tricyclic Antidepressant Drugs Test System is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.
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 Tricyclic Antidepressant Drugs Test System
FDA 510K for Tricyclic Antidepressant Drugs Test System Device Code and Regulation Number
| S.
No. |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
|
1 |
U.V. Spectrometry, Tricyclic Antidepressant Drugs | Tricyclic Antidepressant Drugs Test System |
862.3910 |
2 |
U.V. Spectrometry, Tricyclic Antidepressant Drugs
Intended Use
The Tricyclic Antidepressant Drugs Test System is a diagnostic device that measures the concentration of tricyclic antidepressant drugs (e.g., amitriptyline, nortriptyline, desipramine) in human serum, plasma, or urine. Used in the treatment of depression, anxiety, and other psychiatric conditions, it helps monitor therapeutic drug levels to ensure appropriate dosing, avoid toxicity, and manage overdose risks. Clinical judgment should be applied in interpreting results, especially when preliminary positive results are obtained. It is intended for In Vitro Diagnostic Use Only.
Device Description
This is an enzyme immunoassay used to detect tricyclic antidepressants in serum, plasma, or urine. It uses ready-to-use reagents and specific antibodies, measuring enzyme activity inversely related to drug concentration. The kit includes Reagent A (anti-tricyclic antibodies and substrates) and Reagent E (enzyme-conjugated drug) for accurate therapeutic drug monitoring.
Performance Testing (Analytical) for Tricyclic Antidepressant Drugs Test System
- Precision (Reproducibility and Repeatability)
- Spike recovery
- Dilution Linearity
- Method Comparison and Accuracy
- Matrix equivalency
- Specificity
- Interference
Clinical Testing
No Guidance available for 510k submission