FDA 510K for Vitamin D Test System
The Vitamin D test system is an in vitro diagnostic (IVD) device used to measure vitamin D levels in human serum or plasma.
Intended Use of Vitamin D Test System
A Vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.
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 Vitamin D Test System
FDA 510K for Vitamin D Test System Device Code and Regulation Number
| S.
No. |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | MRG | System, Test, Vitamin D | Vitamin D Test System | 862.1825 | 2 |
System, Test, Vitamin D
Intended Use
The Vitamin D Test is designed for use in clinical labs to measure the levels of 25-hydroxyvitamin D (25-OH-D) in human blood serum and plasma. This test is performed on automated machines and helps assess if a person has enough vitamin D. It’s for diagnostic use only, meaning it’s used outside the body for testing.
Device Description
The device is a Vitamin D test system intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in human serum or plasma to be used in the assessment of vitamin D sufficiency. The test system includes the necessary reagents and analytical components to measure these analytes and provide numerical results that support clinical evaluation of a patient’s vitamin D status. The system uses a specific analytical method, such as an immunochemical binding reaction or chromatographic separation, followed by detection, in which the target analyte interacts with reagents designed to produce a measurable signal. The intensity of the generated signal is proportional to the concentration of vitamin D in the specimen and is processed by the system to generate a quantitative result for clinical assessment.
Performance Testing (Analytical) for Vitamin D Test System
- Precision (Reproducibility and Repeatability)
- Linearity
- Traceability, Stability, Expected values (controls, calibrators, or methods)
- Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ)
- Specificity
- Interfering substance
- Comparison studies
- Cross reactivity
- Reference range
- Specimen equivalence
- Stability
Clinical Testing
No Guidance available for 510k submission