SOUTH AFRICA – The Mitra micro sampling device from US-based Neoteryx has been approved as a Class B in vitro diagnostic (IVD) medical device by the South African Health Products Regulatory Authority (SAHPRA) in South Africa.
Separations, a South African-based distributor of devices and products for scientists and labs, helped get the Mitra device approved for broad use in South Africa. Class B registration allows lay people to use the Mitra to self-sample at home for research studies or monitoring non-critical conditions.
The Mitra device is ideal for remote use by both professionals and laypersons to collect a small blood sample using a simple finger-stick method.
It is based on volumetric absorptive micro sampling technology, made possible by the absorbent VAMS® tip. Mitra devices can be used at home, in the field or lab, and many scientists around the world use them for remote research studies, clinical trials, and public health surveys.
“The SAHPRA registration confirms that Mitra devices from Neoteryx meet all regulatory and quality standards in South Africa and can be imported for application in research and lab settings,” said Nicolas Queisser, Managing Director, Separations.
Mitra devices can be shipped from Separations on behalf of researchers and labs via regular mail to research volunteers living in remote areas. With the availability of Mitra devices, more South African citizens will be able to provide specimen samples without having to travel to labs or facilities in city centers.
With the help of online video demonstrations and illustrated instructions in Mitra Collection Kits, people can use Mitra devices to collect high-quality blood samples for validated lab testing. The data gathered from Mitra microsamples can be used for both scientific research and clinical diagnostics.
Mitra microsamples are intended to be analyzed in labs as dried specimen samples, a method that keeps bio-specimens stable and eliminates the need for cold shipping and storage.
Remote collection and micro sampling of dried specimens are ideal for remote monitoring or studies in low-resource areas and for virtual clinical trials or public health studies where people can easily participate from home.
South Africa’s approval follows China’s approval of the device in August this year. The Mitra device met all regulatory approval requirements of the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration.
“The Chinese NMPA registration confirms that Mitra® devices from Neoteryx have met all regulatory and quality standards in China and can be imported into the country for use in both research and clinical applications,” said Loc Huynh, MS, RAC, Regulatory Affairs and Quality Director, Neoteryx.