RDA Spot DBS Sample Collection Card and Kit have been developed in collaboration with laboratories, potential users of blood DBS sample collection cards and manufacturers of materials. Detailed analysis of research articles about DBS sampling and experience of medical institutions, as well as accurate examination of special materials and technologies allowed to design a card, which can be easily used by both practitioners and patients.
In order to create a safe, useful and quality product, which meets the requirements of the European Union for medical devices, the technical requirements are reviewed and supplemented in accordance with the Safety Regulations for In Vitro Diagnostic Medical Devices (Instruments), the MEDDEV Recommendations, and the recommendations of NB-MED.
RDA Spot DBS Sample Collection Card was tested by the independent laboratory. Dried blood spot sample versus liquid blood sample laboratory test results reported that a sample aliquot obtained from RDA Spot DBS sample collection card achieved the same level of accuracy and precision as that from an equal pipette volume of a liquid blood sample. The measured relative content in the eluate from the extracted RDA Spot DBS sample collection card punch replicated the level in the original blood sample.
RDA Spot DBS Sample Collection Card and Kit were evaluated by State Service of Accreditation for Health Care Activity under the Ministry of Health and is CE registered supplied to the market medicine measure (device).
To ensure that RDA Spot DBS Sample Collection Card and Kit are safe to use and will not endanger the third parties, risk analysis was carried out and risk identification and management measures have been determined. RDA Spot has certified ISO 13485 Quality Management System.
RDA Spot Sample Collection Card and Kit do not contain any medicines.
RDA Spot Sample Collection Card and Kit do not contain non-viable animal origin material.
RDA Spot Sample Collection Card and Kit do not contain any specific substances that could cause adverse reactions.
After sampling RDA Spot Sample Collection Card is dried at room temperature. RDA Spot Sample Collection Card can be safely sent by regular post or by courier.
Package requirements were determined after investigation of the recommendations of scientific articles and researches, recommendations of the Quality Assurance and Standardization Program Laboratories (USA), recommendations of the shipping companies and the legal basis European Union.
RDA Spot Sample Collection Cards and Kits are manufactured only from certified materials in accordance with the European Parliament and Council Directive 98/79/EC on medical devices for in vitro diagnostic and ISO 13485 requirements for quality management systems of medical devices.
RDA Spot Sample Collection Cards and Kits are manufactured in accordance with the established production process and strict control system.
The labeling and instructions of RDA Spot Sample Collection Cards and Kits correspond with the requirements of the European Union In Vitro Diagnostic Medical Device (Instrument) Safety Technical Regulation.