Nova Max Creatinine/eGFR is an important new tool to improve kidney care through detection of kidney disease early enough to successfully treat the disease. Nova Max is a fast, accurate and easy to use meter and biosensor for kidney function testing. The measurement technique is very easy to use, virtually identical to the use of a glucose meter by people with diabetes. Creatinine and estimated glomerular filtration rate (eGFR) results are reported (with or without race as a factor) using the CKD-EPI equation from a small, capillary fingerstick blood sample in just 30 seconds. Test results can be wirelessly communicated to Bluetooth enabled applications for review and intervention by healthcare professionals.
Specifications
Test Measured: Creatinine
Tests Reported: Creatinine, eGFR
Test Time: 30 seconds
Test Strip Volume: 1.2 µL
Test Methodology: Electrochemistry
Weight: 75g (0.2 lbs)
Size: 2.36 in x 3.7 in x .62 in (6 cm x 9.4 cm x 1.6 cm)
Sample Types and Operating Modes:
Whole Blood: Capillary
Measurement Range:
Creatinine: 0.30-7.00 mg/dL or 27-619 μmol/L
Operating Ranges:
Temperature: 59˚F – 104˚F (15˚C – 40˚C)
Altitude: 15,000 feet (Up to 4,500 meters)
Humidity: 10% to 90% relative humidity
Test Strips and Reagents:
Test Strip Refrigerated Storage: 12 months 36˚F – 46˚F (2˚C – 8˚C)
Test Strip In-Use Stability: 3 months
Quality Control 3 levels (low, normal, high)
Data Storage:
Patient and QC Tests: 400
eGFR:
CKD-EPI2021
FDA Labeling:
For in-vitro diagnostic use
Connectivity:
Meter Data Output: Wireless Bluetooth connectivity
Battery Information:
Type: 3.7V Li Polymer Rechargeable Battery
Additional Features:
• LCD large color display • Traditional QC with target values assigned to QC materials • Units of measure based on meter (mg/dL or µmol/L) • Automatic shut-off when not in use • Automatic sample detection and analysis • Automatic sample counting with date/time stamp for data tracking
Optional Carry Case:
Robust plastic storage/carry case holds meter, test strips, controls vials, lancets, charging cord with plug, quick reference guide, and removable meter stand.
Certifications and Compliance:
ISO 13485:2016 Quality System Registration, IVDD, CE Self Declared, Tested according to: EN 61010-1:2010, EN 61010-2-101:2015