mitra microsampler now registered at FDA as a medical device
by Neoteryx, on January 18,2016
Torrance, CA (January 18, 2016) – Neoteryx’s device for direct specimen collection of blood and other biological fluids is now registered at the U.S. Food and Drug Administration (FDA) as a Class 1 Medical Device.
In seconds, the device based on Volumetric Absorptive Microsampling (VAMS™) technology accurately collects 10 µL of blood from a fingerstick or other method for obtaining low volumes. Elimination of a venipuncture improves the patient experience by minimizing pain and needle anxiety. Furthermore, the simplicity and accuracy of the device enables patient self-sampling which provides the convenience of at-home or remote sample collection. Four device configurations are offered to meet varying sampling requirements.
In addition to patient benefits, the Mitra® Microsampler increases the efficiency, efficacy, and profitability of lab operations. Samples collected with the Mitra device are transported to the lab in the absence of cold chain shipping logistics or couriers eliminating significant costs. Upon arriving at the lab, patient samples collected on the device can be stored at room temperature and then funneled into extraction workflows that are compatible and automatable with liquid handling and analytical instrumentation typical to most labs.
“Laboratories now have access to a revolutionary device for the collection of patient samples to be analyzed within their laboratory-developed tests,” says Bert Rietveld, Neoteryx President. “The Mitra Microsampling collection device is a major advance insofar as it improves the patient experience, opens up opportunities for in-home patient sampling, and greatly reduces logistical expenses.”
The Mitra Microsampling device is suitable for specimen collection across all patient populations and is especially well suited for those that have low blood flow such as pediatrics, elderly, or oncology.
The Mitra Microsampler class I medical device is for direct specimen collection of blood and other biological fluids. It is not specific to any clinical test, and is not for use in diagnostic procedures. Use of the Mitra Microsampler in Laboratory Developed Tests (LDTs) requires further processing including the establishment of performance characteristics and successful validation by the laboratory in a manner consistent with CLIA requirements.