BK261331- ORTHO Optix™ Reader
The FDA has cleared the ORTHO Optix™ Reader, an automated system for reaction grading, results interpretation, and data management in immunohematology testing using ID-MTS™ Gel card technology.
The manufacturer (Ortho Clinical Diagnostics), clinical laboratory professionals in blood banks, and regulatory personnel overseeing in vitro diagnostic testing systems.
The introduction of automated reaction grading for blood testing suggests a shift toward reducing manual interpretation variability in immunohematology. Lab managers and regulatory teams may need to evaluate how this automated interpretation and data management system integrates with existing manual or semi-automated workflows to ensure continued data integrity and result accuracy.
Regulatory and QA teams should ensure that site-specific validation protocols for Automated Reaction Grading (ARG) align with the cleared use of ID-MTS Gel card technology. Validation must specifically address data management integration between the reader and existing laboratory information systems.
The ORTHO Optix™ Reader is a system designed to automate reaction grading, results interpretation and data management when performing in vitro immunohematology testing of human blood utilizing ID-MTS™ Gel card technology.
Open in openFDA / FDA.gov