FDA 510K for Folic Acid Test System
The Folic Acid Test System is designed to measure folic acid (Vitamin B9) levels in human samples, primarily serum or plasma. It plays a crucial role in diagnosing folate deficiencies, monitoring nutritional status, and evaluating the risk of conditions such as anemia and neural tube defects.
Intended Use of Folic Acid Test System
A Folic Acid Test System is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of Megaloblastic Anaemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.
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 Folic Acid Test System
FDA 510K for Folic Acid Test System Device Code and Regulation Number
| S.
No. |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | CGN | Acid, Folic, Radioimmunoassay | Folic Acid Test System | 862.1295 | 2 |
Folic Acid Test System
Intended Use
It is used for the in vitro quantitative determination of folate in erythrocytes (Red Blood Cells(RBC)). Folate measurements aid in the diagnosis and treatment of anemia. This assay utilizes an Electrochemiluminescence Immunoassay (ECLIA) method and is designed for use on immunoassay analyzers. It is used as a prescription device.
Device Description
The Folate Binding Assay is a competitive Electrochemiluminescence Immunoassay (ECLIA) used for the quantitative determination of folate in erythrocytes to aid in anemia diagnosis and treatment.
The whole blood, treated with anticoagulants, is mixed with ascorbic acid and incubated to lyse RBCs, releasing and stabilizing intracellular folate. The resulting hemolysate is analyzed using a calibration curve generated through 2-point calibration and a master curve provided via the system link.
Performance Testing (Analytical) for Folic Acid Test System
- Precision (Reproducibility and Repeatability)
- Sensitivity
- Linearity
- Dilution
- Endogenous and Exogenous Interferences
- Analytical Specificity/Cross-Reactivity
- Sample Matrix Comparison
- Reagent stability
- Calibration Stability
- Comparison studies
- Limit of Detection (LoD), Limit of Quantification (LoQ) and Limit of Blank (LoB)
Clinical Testing
No Guidance available for 510k submission