Nova Max Creat eGFR Monitoring System

The Nova Max Creat eGFR Monitoring System is a handheld device that measures creatinine levels in capillary fingerstick blood samples and calculates estimated glomerular filtration rate (eGFR) to monitor kidney function. It is intended for home use by prescription only for adult patients aged 18 and above as an aid to monitor kidney health under a treating healthcare professional's order.

The device uses enzyme amperometry to measure creatinine with a measurement range of 0.30–7.00 mg/dL (compared to predicate's 0.3–12.0 mg/dL). It employs the CKD-EPI 2021 equation for eGFR calculation, operates in 30 seconds, supports a hematocrit range of 20–70% (vs. predicate's 30–60%), and includes two levels of quality control. The monitor is smaller (95.25 × 61.98 × 18.80 mm, 90 grams) and portable with a 2.8-inch color touchscreen, rechargeable battery, and 400-result storage capacity.

CLSI EP5-A3 (Evaluation of Precision Performance of Quantitative Measurement Methods) was cited as guidance for precision testing. Traceability to NIST Standard Reference Material 967b was established for creatinine control materials.

The Nova Max Creat eGFR is substantially equivalent to the predicate Nova StatSensor Creatinine Hospital Meter System because both measure creatinine and calculate eGFR using the same enzyme-amperometry operating principle, identical sample volume (1.2 µL), same 30-second analysis time, same sample application method, and comparable test ranges. Performance data demonstrate strong clinical accuracy (correlation coefficient 0.9951), appropriate precision, no clinically significant interferents, and successful flex studies validating robustness.