Promega has received CE mark for Maxwell 16 IVD system, in accordance with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. The CE mark applies to the instrument, the Maxwell 16 Blood DNA Purification System and the Maxwell 16 Viral Total Nucleic Acid Purification System.
Promega’s Maxwell 16 IVD System works to the specific needs of a clinical lab. Addressing the pressure to deliver quick results, especially in the process to determine organ compatibility or to diagnose infectious disease, Maxwell extracts multiple samples faster than manual methods. Up to 16 samples can be purified simultaneously, without user intervention and with higher yield and greater consistency. The design of Maxwell 16 prevents cross contamination.
The bench top automation system is fully compliant with the IVD directive and supports European clinical laboratories performing diagnostic tests in molecular pathology, transplant HLA, and Infectious disease.
The new Maxwell 16 IVD System extracts DNA from whole or fractionated blood using the Maxwell 16 Blood DNA purification system, or viral nucleic acid from plasma or serum samples using the Maxwell 16 Viral total nucleic acid purification system. The extracted nucleic acids are then used in standard amplification-based diagnostic assays conducted by European clinical labs. The system is fully integrated with pre-filled instrument cartridges and pre-programmed protocols.
Ashley Anderson, chief medical officer, said: “The Maxwell 16 IVD includes integrated bar code reading to help reduce transcription errors, a UV lamp to assist in sanitization of the unit and its compact enough to operate inside a bio-safety cabinet. Enabling technologies like the Maxwell 16 can make a meaningful difference in clinical labs that face the accelerated demands of healthcare.
“Labs have told us repeatedly how quickly and accurately they can deliver life saving information and how easy it is to train new technicians. For some it’s actually advanced the services they offer.”
Promega is a provider of solutions and technical support to the life sciences industry. The company’s products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, molecular diagnostics and human identification.