FDA 510K for Benzodiazepine Test System
A Benzodiazepine Test System is a device that detects the presence of benzodiazepines in urine, blood, or plasma. Benzodiazepines are a class of drugs that depress the central nervous system. They are also known as tranquilizers, sleeping pills, and muscle relaxants.
Intended Use of Benzodiazepine test system
A Benzodiazepine Test System is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, clorazepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines 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 forBenzodiazepine Test System
FDA 510K for Benzodiazepine Test System Device Code and Regulation Number
| S.NO | Product Code | Device | Regulation Description | Regulation Number | Device Class |
|
1 |
Enzyme Immunoassay, Benzodiazepine | Benzodiazepine Test System |
862.3170 |
2 |
Enzyme Immunoassay, Benzodiazepine
Intended Use:
The Benzodiazepine Test System is an in vitro diagnostic device intended for the qualitative detection of benzodiazepines and/or their metabolites in human urine or other specified clinical specimens to aid in the diagnosis and monitoring of patients suspected of benzodiazepine use or exposure
Device Description:
The Benzodiazepine Test System is an enzyme immunoassay that comprises reagents, controls, calibrators, and necessary assay components used on a compatible analyzer to detect benzodiazepines in patient specimens. The mode of action is based on a competitive immunochemical reaction in which benzodiazepines in the specimen compete with labeled benzodiazepine analogs for binding to specific antibodies; the amount of signal generated inversely correlates with the concentration of benzodiazepines present, providing a qualitative result.
Performance Testing (Analytical) for Benzodiazepine Test System
- Reagent Stability
- Precision/Reproducibility
- Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
- Linearity/assay reportable range
- Traceability (controls, calibrators, or method)
- Analytical specificity (cross reactivity)
- Accuracy(recovery)
- Interfering Substances
Clinical Testing:
No Guidance available for 510k submission