US FDA listing of Trajan’s hemaPEN blood microsampling device

July 02, 2020

Trajan Scientific and Medical (Trajan) has listed its hemaPEN^® blood microsampling device with the U.S. Food and Drug Administration (US FDA) as Class I for therapeutic and in vitro diagnostic (IVD) use.

This follows the hemaPEN’s recent registration in May for supply in the EU and UK as a General IVD; as well as inclusion in the TGA’s ARTG (Australian Register of Therapeutic Goods) in February as a Class I IVD.

This enables hemaPEN to be used to collect blood microsamples for clinical trials, diagnostics and applications to monitor health.

hemaPEN provides a convenient sampling procedure for collection and storage of four dried blood spot (DBS) samples. Unlike conventional DBS sampling tools, hemaPEN enables collection of an accurate and precise fixed micro-volume and is designed to maintain sample integrity for quantitative analysis. An easy-to-use sophisticated microsampling tool in the hands of non-analysts.

Remote microsampling facilitates more flexible blood sampling compared to traditional phlebotomy (blood draw) for scientific and clinical communities, for rapid R&D and implementation of new healthcare solutions for the public.

Trajan believes in science that benefits people – creating portable and affordable measurement solutions, enabling accurate results to inform preventative healthcare.

Visit www.hemapen.com to purchase or learn more about hemaPEN, and to sign up for updates.

To learn more about Trajan’s microsampling technologies and capabilities visit www.trajanscimed.com/microsampling.

Download
Press release [PDF]

Featured publication
Deprez, S. et al. “Evaluation of the Performance and Hematocrit Independence of the hemaPEN as a Volumetric Dried Blood Spot Collection Device.” (Analytical Chemistry 2019 91 (22), 14467-14475)

More information
www.hemapen.com

Media contact information
Trajan Scientific and Medical
Tel: +44 (0) 7703 828 309
media@trajanscimed.com

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