FDA 510K for Automated Blood Grouping and Antibody Test System
An Automated Blood Grouping and Antibody Test System is a device that identifies blood types and detects antibodies in the blood. It’s used in blood banks and donation centers to type blood before transfusions.
Intended Use of Automated Blood Grouping and Antibody Test System
An Automated Blood Grouping and Antibody Test System is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
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 Automated Blood Grouping and Antibody Test System
FDA 510K for Automated Blood Grouping and Antibody Test System Device Code and Regulation Number
System, Test, Automated Blood Grouping and Antibody
Intended use It is intended for use in centrifugation as part of vitro immunohematology testing of human blood. Specifically, it is used for:
- ABO+D Blood Grouping (including weak D and partial D testing)
- Rh Phenotype and Kell Blood Grouping
- Antibody Detection and Identification
- Red Blood Cell Alloantibody Testing
- AHG Crossmatching
- Auto Control and Direct Antiglobulin Testing
Device Description:
These tests are used to determine the presence or absence of specific antigens, antibodies, or other markers in blood, which is crucial for blood transfusions, patient compatibility, and overall blood safety. This is the primary mechanism used to separate components based on density differences. The device is designed for hands-off operation once the sample is loaded, making it user-friendly and reducing the chance of operational errors.it is a laboratory instrument designed for centrifugation and used in immunohematology testing. These tests are critical for blood typing and antibody screening, among other procedures. The centrifuge is specifically built for use in blood banks, clinical laboratories, and other settings where blood testing is performed.
Manual Blood Grouping and Antibody Test System
Intended use:
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Device Description:
An automated blood grouping and antibody test system is a sophisticated diagnostic device designed to classify blood types and detect antibodies against blood group antigens with high precision and efficiency. components typically include an automated sample handling system, advanced immunoassay technology, a user-friendly interface for operation, data management software for result tracking and analysis, and built-in quality control mechanisms. This system is widely used in blood banks and clinical laboratories to ensure safe blood transfusions, enhance testing throughput, and reduce human error, ultimately supporting effective patient care.
Performance Testing (Analytical) for Automated Blood Grouping and Antibody Test System
- Precision (Repeatability & Reproducibility)
- Method Comparison / Concordance
- Analytical Sensitivity / Specificity
- Interference Testing
- Environmental Stress / Robustness
- Sample Stability
- Limit of Detection / Analytical Limits
- Concordance and Confidence Intervals
- Card/Reagent Specific Performance Validation
- Software Verification / Reaction Interpretation
Clinical Testing:
No Guidance available for 510k submission.