Nova Biomedical has announced the availability of its blood glucose laboratory analyser.
The Nova Primary analyser will be available for sale in CE regulated countries as of January 2021. The Nova Primary was also submitted to the U.S. Food and Drug Administration (FDA) for 510(k) clearance in November 2020 and is anticipated to receive clearance by the FDA in the first half of 2021.
Nova Primary uses a single, reusable glucose electrochemical sensor based on glucose oxidase and has a measurement range of 10-900 mg/dL. It uses a small, 25 microlitre venous whole blood or plasma sample which is internally diluted like the YSI. Results are available in approximately two minutes.
A single calibrator pack uses RFID data management to monitor the pack expiration date and number of samples remaining, eliminating the need for separate reagent bottles and daily monitoring of their levels. In clinical laboratory studies using venous whole blood and plasma it demonstrated excellent correlation to the YSI 2300 and is traceable to NIST glucose standards.
The Nova Primary uses a comma delimited (.csv) format data output that can be downloaded via the integral USB data port. The analyser measures 17 in x 11 in x 18 in (44 cm x 28 cm x 46 cm).
