FDA 510K for Vitamin B12 Test System
The Vitamin B12 Test System is an in vitro diagnostic device designed to measure the level of vitamin B12 in human blood. It is essential for diagnosing vitamin B12 deficiency, which can contribute to conditions like anemia, neurological issues, and other health complications. Accurate testing helps healthcare providers determine the appropriate course of treatment and monitor patient health.
Intended Use of Vitamin B12 Test System
A Vitamin B12 Test System is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anaemias of gastrointestinal malabsorption.
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 B12 Test System
FDA 510K for Vitamin B12 Test System Device Code and Regulation Number
Radioassay, Intrinsic Factor Blocking Antibody
Intended Use
This is a type of blood test that uses a special chemical reaction to detect intrinsic factor antibodies in human serum and plasma. It is performed on Access Immunoassay Systems and is used to help diagnose pernicious anaemia. This test is for in vitro diagnostic use only, meaning it’s used outside the body for testing purposes.
Device Description
The Vitamin B12 Test System is an in vitro diagnostic device designed to quantitatively measure the concentration of vitamin B12 in human serum or plasma samples. This test system is used to assess vitamin B12 levels to help diagnose conditions such as vitamin B12 deficiency, anemia, and neurological disorders.
This is a type of test that uses a chemical reaction to detect intrinsic factor antibodies. The test includes a reagent pack, calibrators, and quality controls (QCs). To perform the test, additional items like substrate and wash buffer are also required.
Radioassay, Vitamin B12
Intended Use
This is a type of blood test that uses a chemical reaction to measure the level of Active-B12 (Holotranscobalamin) in human serum. It helps doctors diagnose and manage vitamin B12 deficiency.
Device Description
The Vitamin B12 test is a type of blood test that uses a chemical reaction to measure vitamin B12 levels. The test kit comes in a liquid, ready-to-use format for best performance on Beckman Coulter’s immunoassay analyzers. The kit includes two reagent packs, and additional items needed to run the test are substrate, calibrators, and wash buffer.
Performance Testing (Analytical) for Vitamin B12 Test System
- Imprecision (Reproducibility and Repeatability)
- Linearity
- Accuracy
- Comparison studies
- Specificity and Sensitivity
- Cross reactivity study
- Reference interval
- Proficiency sample testing
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
Clinical Testing
No Guidance available for 510k submission