US FDA grants 510(k) clearance to Sebia’s CAPILLARYS 3 DBS devices
Overview
Sebia, a global specialty diagnostic company, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.
Their Solution
- Our solution is intended for the detection of normal haemoglobins (F and A) and abnormal haemoglobins (S, C, E, D and Bart’s) in blood from human newborn collected on filter paper.
- This qualitative analysis is performed by capillary electrophoresis with the CAPILLARYS 3 DBS automated instrument.
- This offer provides laboratories a gain in operational efficiency with high throughput and a full traceability from DBS card up to the result through a cyber-secured environment.
Words from Sebia Group
As a global leader for haemoglobinopathy testing, Sebia is expanding its portfolio in the United States with this innovative solution, which can be easily integrated into the laboratory workflow significantly reducing manual intervention while ensuring comprehensive traceability. This will help laboratories to make timely and accurate decisions for newborns” said Arnaud Collin, Sebia Group vice president global regulatory affairs & quality.
About Sebia Group
- Founded in 1967, Sebia is a world-leading provider of clinical protein electrophoresis equipment and reagents, a technology used for in vitro diagnostic testing.
- Its systems analyze proteins in order to screen and monitor various diseases and conditions; primarily oncology (multiple myeloma) and metabolic disorders such as diabetes, also hemoglobinopathy and rare pathologies.
