Sebia Receives U.S. FDA Clearance for the CAPILLARYS 3 DBS devices

April 5, 2024 |

1 min read

Sebia announced that it has received 510 clearance from the U.S. Food and Drug Administration for CAPILLARYS 3 DBS devices. Our solution is intended for the detection of normal hemoglobins and abnormal hemoglobins in blood from human newborn collected on filter paper.

The next generation instrument for screening hemoglobin disorders in newborns.

LISSES, France--(BUSINESS WIRE)-- Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.

Our solution is intended for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (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.

“As a global leader for hemoglobinopathy 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.

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ABOUT Sebia
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.

Following the acquisition of Orgentec, Corgenix, Arotec in 2021, and of Zeus Scientific in 2022, Sebia now develops and markets innovative solutions for autoimmunity diagnostics.

Headquartered in Lisses, France, the company operates across more than 120 countries. Sebia is owned by CVC Capital Partners, Tethys Invest and the Caisse de Dépôt et Placement du Quebec (CDPQ).
https://www.sebia.com