Capitainer Initiates Clinical Sampling for HbA1c FDA 510(k) Study

STOCKHOLM, October 27, 2026 /PRNewswire/ -- Capitainer, a Swedish provider of volumetric microsampling solutions, has reached an important milestone in its U.S. regulatory strategy with the first clinical sample collected as part of its study on HbA1c, a marker of long-term blood glucose levels, intended to support a planned FDA 510(k) submission.

The study is expected to include at least 120 participants and will evaluate both self-sampling and assisted capillary blood collection using Capitainer®B50. HbA1c results will be compared against those obtained from conventional venous blood samples. The samples collected during the study will be analyzed by Three Rivers Diagnostics and Aegis Sciences Corporation using laboratory instrumentation from Roche. Data collection is expected to be completed in November 2026. 

"Reaching this milestone is an important step in our continued development in the U.S. market. We see significant opportunities for microsampling technology to support more accessible blood testing and help healthcare providers address gaps in care. This study represents an important part of our long-term strategy to expand the clinical applications of our technology," says Christopher Aulin, CEO of Capitainer.

For more information, please contact:

Christopher Aulin, CEO
Phone: +46 (0)708 977577
Email: [email protected]

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SOURCE Capitainer AB