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Sebia Gains FDA 510(k) Clearance for Hemoglobin Disorder Analyzer

NEW YORK – French specialty diagnostic firm Sebia said on Friday that it has received US Food and Drug Administration 510(k) clearance for an automated instrument that is used to aid the identification of hemoglobin disorders in newborns.

The company's Capillarys 3 DBS instrument is used for the qualitative detection by electrophoresis of normal hemoglobins F and A and abnormal hemoglobins S, C, E, D, and Bart's in a dried blood spot sample that is collected on filter paper. The firm said that the instrument provides high-throughput and full traceability from sample to results.

"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," Arnaud Collin, Sebia group VP of global regulatory affairs and quality, said in a statement.

The firm also received 510(k) clearances earlier this year for modifications to its FLC Kappa and FLC Lambda ELISAs that had been used to aid the diagnosis of multiple myeloma and AL amyloidosis and now can also be used to monitor those conditions.

Sebia operates in about 120 countries and is a provider of clinical protein electrophoresis instruments and reagents that are used to analyze proteins in the screening and monitoring of cancers, metabolic disorders, hemoglobinopathy, and other rare pathologies.