RDA Card© has been developed in collaboration with laboratories, potential users of blood DBS 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 Card© was tested by the independent laboratory. RDA Card© dried blood spot sample versus liquid blood sample laboratory test results reported that a sample aliquot obtained from a RDA Card© dried blood spot 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 Card© DBS punch replicated the level in the original blood sample.
RDA Card© was 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 Card© is safe to use and does not endanger third parties, risk analysis was carried out and risk identification and management measures have been determined.
RDA Card© does not contain any medicines.
RDA Card© does not contain non-viable animal origin material.
RDA Card© does not contain any specific substances that could cause adverse reactions.
After sampling RDA Card© is dried at room temperature. RDA Card© can be safely sent by 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 Card© DBS cards 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 Card© DBS cards are manufactured in accordance with the established production process.
The labeling and instructions of RDA Card© DBS cards correspond with the requirements of the European Union In Vitro Diagnostic Medical Device (Instrument) Safety Technical Regulation.