FDA 510K for Hemoglobin A1c Test System
A Hemoglobin A1c (HbA1c) Test System is an in vitro diagnostic (IVD) device designed for the quantitative measurement of HbA1c levels in whole blood. It plays a crucial role in assessing long-term glucose control in individuals with diabetes mellitus and serves as an essential tool in diabetes diagnosis and management.
Intended Use of Hemoglobin A1c Test System
A Hemoglobin A1c Test System is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.
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 Hemoglobin A1c Test System
FDA 510K for Hemoglobin A1c Test System Device Code and Regulation Number
| S.
No. |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | PDJ | Hemoglobin A1c Test System | Hemoglobin A1c Test System | 862.1373 | 2 |
Hemoglobin A1c Test System
Intended Use
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Device Description
The device is an In-Vitro Diagnostic (IVD) Reagent Kit designed for prescription use to detect glycated hemoglobin. It operates on the principle of capillary electrophoresis in free solution, where charged molecules are separated based on their electrophoretic mobility in an alkaline buffer with a defined pH. The separation process is influenced by electrolyte pH and electroosmotic flow, ensuring precise molecular differentiation.
Performance Testing (Analytical) for Hemoglobin A1c Test System
- Precision (Reproducibility and Repeatability)
- Accuracy
- Sensitivity
- Linearity
- Traceability, Stability (controls, calibrators, or methods)
- Comparison studies
- Total error
- Endogenous, Hemolysis and Drug Interference
- Cross reactivity with Hemoglobin Derivatives
- Hemoglobin Variants Interference
- Expected Values/ Reference Range
Clinical Testing
No Guidance available for 510k submission