Revvity, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone.
Key features of the new test include:
- The only FDA-cleared ChLIA assay for direct quantitative measurement of free testosterone in human serum or plasma.
- Rapid results on EUROIMMUN’s ChLIA platforms with the first result available in just 48 minutes and an estimated throughput of nearly 60 tests per hour.
- Incorporation of monoclonal antibodies to ensure specificity and consistent performance across test batches.
The assay is processed on the Company’s random-access iSYS or i10 instruments to deliver quick turnaround times and high-throughput testing with minimal technician training and expertise. The assay provides direct measurement of free testosterone levels in a single test, enhancing diagnostic capabilities for conditions such as hypogonadism, impotence, polycystic ovarian syndrome (PCOS), and other androgenital syndromes.
For more information about EUROIMMUN and its diagnostic solutions, please visit this webpage.
