December 2022—The FDA has cleared Nova Biomedical’s Nova Primary blood glucose reference analyzer. Nova Primary is designed to replace the YSI Stat Plus 2300 Glucose and L-Lactate analyzer, which has been discontinued by YSI.
Nova Primary uses a single, reusable glucose electrochemical sensor based on glucose oxidase and has a measurement range of 20 to 900 mg/dL. It uses a small, 25-µL venous whole blood or plasma sample, which is internally diluted. Results are available in about two minutes.
The analyzer features a large color touchscreen display and an intuitive, icon-based graphic user interface. A single calibrator pack uses RFID data management to monitor the expiration date of the pack and the number of samples remaining.
The Nova Primary demonstrated excellent correlation to the YSI 2300 in clinical laboratory studies using venous whole blood and plasma, the company said in a press release, and is traceable to NIST glucose standards. It is available worldwide.
Nova Biomedical, 781-894-0800