FDA 510K for Tacrolimus Test System
The Tacrolimus Test System measures the concentration of tacrolimus, an immunosuppressant drug, in a patient’s blood, crucial for patients undergoing liver or kidney transplants to maintain therapeutic levels during treatment. The testing uses two methods: LC-MS/MS and immunoassay, providing accurate measurements for patient management. Blood is drawn from an arm vein, and measurements typically measure post-dose levels. The primary purpose of the Tacrolimus Test is to determine the current levels of tacrolimus in the body, ensuring the drug’s efficacy and safety for each patient.
Intended Use of Tacrolimus Test System
A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus
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 Tacrolimus Test System
FDA 510K for Tacrolimus Test System Device Code and Regulation Number
| S.
NO |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | MLM | Enzyme Immunoassay, Tracrolimus | Tacrolimus test system. | 862.1678 | 2 |
Enzyme Immunoassay, Tracrolimus
Intended Use:
The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood. The assay is used as an aid in the management of liver and kidney transplant patients receiving tacrolimus therapy.
Device Description:
The Tacrolimus Assay Kit utilizes the latex-enhanced competitive immunoturbidimetry method for quantitative determination of the tacrolimus concentration in human whole blood. It quantitatively measures tacrolimus concentrations in human whole blood as an aid in the therapeutic monitoring of transplant patients receiving tacrolimus therapy. The test operates on an immunoassay principle, in which tacrolimus in the sample binds to specific antibodies. The resulting reaction is then detected and measured by the system to generate a quantitative result. Test results are intended to be used in conjunction with other clinical and laboratory information. The assay consists of reagents, a sample extract, and a calibrator.
Performance Testing (Analytical) for Tacrolimus Test System
- Reagent Stability
- Precision/Reproducibility
- Accuracy(recovery)
- 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
- Analytical Sensitivity
- Interfering Substances
Clinical Testing:
No Guidance available for 510k submission