Development of a VAMS Blood Sampling Technique For Monitoring IGF-1 in Patients With Acromegaly
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.
Micro blood samples collected on the Mitra microsampler is compatible with downstream immunoassay analyzers.
Comparison of IFG-1 result in plasma vs. VAMS extracted with whole blood
Comparison of IGF-1 result in serum vs. VAMS extracted with whole blood
Mitra devices are intended as a specimen collector and for the storage and transport of biological fluids. They are CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia, Brazil & China, Class B in South Africa, and registered with health agencies in Canada, Thailand, and Ukraine. In the United States, Mitra devices are for Research Use Only (RUO). In some countries, Mitra devices may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.