FDA 510K for Vancomycin Test System
The Vancomycin Test System is a diagnostic tool designed to quantitatively measure vancomycin levels in human serum or plasma. It is mainly used for therapeutic drug monitoring (TDM) to ensure proper dosing, avoid toxicity, and manage overdose situations. The system typically operates with automated clinical chemistry analyzers, utilizing methodologies such as microparticle agglutination immunoassays or enzyme-linked immunosorbent assays (ELISA) to provide accurate and reliable results for effective patient care.
Intended Use of Vancomycin Test System
A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin 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 Vancomycin Test System
FDA 510K for Vancomycin Test System Device Code and Regulation Number
| Sr.
No. |
Product Code | Device | Regulation Number | Device Class |
|
1 |
Radioimmunoassay, Vancomycin | 21 CFR 862.3950 |
2 |
Radioimmunoassay, Vancomycin
Intended Use
The in vitro test system is designed for the quantitative determination of vancomycin levels in serum and plasma. This device is intended to measure vancomycin, an antibiotic drug, using automated systems. The measurements obtained from this device are used for the diagnosis and treatment of vancomycin overdose and to monitor vancomycin levels, ensuring appropriate therapeutic dosing.
Device Description
This is a two-reagent assay designed for the in vitro quantitative determination of vancomycin levels in human serum or plasma using automated clinical chemistry analyzers. It utilizes a homogeneous microparticle agglutination immunoassay based on the kinetic interaction of microparticles in solution (KIMS). In this assay, a competitive reaction occurs between the drug conjugate and vancomycin in the serum sample, binding to the vancomycin antibody on the microparticles. The resulting kinetic interaction is indirectly proportional to the amount of vancomycin present in the sample.
Performance Testing (Analytical) for Vancomycin Test System
- Precision (Reproducibility and Repeatability)
- Linearity
- Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)
- Interfering substance
- Comparison studies
- Reference range
- Specimen equivalence
- Reagent On-Board Stability
- Reagent Shelf-Life Stability
- Traceability
- Measuring range
Clinical Testing
Required for 510k Submission