Nova Biomedical develops, manufactures, and sells advanced critical care blood gas analyzers and testing meters


StatStrip® and StatStrip Xpress®2 Glucose Meters

The only glucose meters cleared by US FDA and Health Canada for use with all patients, including critically ill

Because of the unacceptably high rate of adverse patient events, including deaths, linked to the point-of-care (POC) use of glucose meters within hospitals, there is a recognized need for more accuracy and better performance standards for POC glucose testing in hospitals, particularly in intensive care settings.

StatStrip is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients.

Proven safety and accuracy

  • In one study of over 17,300 capillary results from critically ill patients that were compared to lab results1
  • In another study of 1,698 arterial and venous results from critically ill patients with over 257 medical conditions were compared to lab results2
  • Improved accuracy results in less insulin misdosing and better outcomes for critically ill patients


Use of any other meter with critically ill patients is considered off label in the U.S. by the FDA and high complexity testing under CLIA

Use of any other glucose meter with critically ill patients is off label
StatStrip is FDA cleared and CLIA waived for use throughout all hospital and all professional healthcare settings including critical care. Use of any other glucose meter with critically ill patients is considered off-label in the U.S. by the FDA and high complexity testing under CLIA.

The personnel testing requirements for off-label use are very demanding and limit who can perform testing. In addition, a hospital must obtain patient consent to perform off-label testing.

The most extensively studied and proven glucose measurement technology
In addition to the studies submitted to the FDA, over 200 independent studies including 53 critical care studies—have found no clinically significant interferences for StatStrip. This is a statement that no other glucose meter manufacturer can make. Download a bibliography of publications here

For more information click here

 

  1. StatStrip Glucose FDA 510K Pre-Market Notification K181043. https://www.accessdata.fda.gov/cdrh_docs/reviews/K181043.pdf  Data on file at Nova.
  2. Dubois J et al. Bedside Glucose Monitoring—Is it Safe? A New, Regulatory-Compliant Risk Assessment Evaluation Protocol in Critically Ill Patient Care Settings. Crit Care Med 2017;45:567-574.

 

Specifications


StatStrip Glucose Connectivity Meter

Available in Mg/dL or mmol/L

Dimensions:
Weight: 0.49 lb (220 g)
Size: 5.8 in x 3.1 in x 1.18 in
(147 mm x 79 mm x 30 mm)

Data Storage:
Patient Tests: 1,000 tests
Patient Records: 3000 individuals*
* With optional ADT interface
QC Tests: 200 tests
Users: 8,000 Operators

Connectivity:
Meter Data Output: RJ-45 Ethernet Port via docking station, optional integrated Wi-Fi (802.11a/b/g/n)
Protocol: TCP/IP Ethernet 100M/1GBPS
Setup Instrument Manager Program: NovaNet™ Device Management Software
Interface Standard: POCT1-A2 Compliant
Connect to hospital ADT via NovaNet Device Management software. Connect to all LIS/EMR via all major middleware providers

Battery Information:
Type: 3.7V Li Polymer Rechargeable Battery
Features: Rechargeable/Replaceable
Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby

Docking Station:
Desk or wall mount docking station with RJ-45 Ethernet jack providing network connection and battery charging. 3 LED indicator lights showing connection status, transmit/receive data, and charging status. Extra battery slot included for recharging and storage of spare battery.

Additional Features:

  • Large color LCD touchscreen
  • Built-in 1D/2D barcode scanner
  • Traditional QC with target values assigned to QC materials
  • Numeric or pass/fail QC
  • QC prompting or QC lock out
  • Abnormal and critical ranges flagged by color highlighting
  • Automatic shut-off when not in use for battery conservation
  • Automatic sample detection and analysis
  • Pre-defined or free text user comments
  • Reject results at meter (optional) for repeat testing
  • Positive Patient ID at the time of testing via 6 unique identifiers
  • Operator certification for lock out of unauthorized users
  • Manual Test Entry for offline tests documentation
  • Entry of ICD-9 and/or ICD-10 diagnosis codes
  • Order physician ID
  • Correlation mode
  • Slope and intercept adjustment
  • Remote meter configuration by medical unit

 

 

 

 


StatStrip Xpress2 Glucose Meter

Available in Mg/dL or mmol/L

Designed for applications that do not need data interfacing and connectivity, Xpress2 Glucose retains all of the analytical performance features of StatStrip Glucose.

Dimensions:
Weight: 2.77 oz (78.5 g)
Size: 3.9 in x 2.4 in x 0.9 in
(98 mm x 61 mm x 22.9 mm)


Data Storage:
Patient & QC Tests: 400 tests total (FIFO)


Connectivity:
Data Transfer: Strip Port Connection to USB
Data Program: Nova Microsoft-Excel based data transfer software


Battery Information:
Type: 2 AAA batteries
Features: Replaceable
Life: Minimum 600 tests


Additional Features:

  • LCD color display
  • Large numeric display (30 mm)
  • Traditional QC with target values assigned to QC materials
  • Units of measure based on meter ordered (mg/dl or mmol/L models)
  • Automatic shut-off when not in use
  • Automatic sample detection and analysis
  • Automatic sample counter with date/time stamp for data tracking

 

 

 

StatStrip Glucose Test Strips

 

Tests:
Tests Measured: Glucose and Hematocrit
Test Reported: Glucose
Test Time: 6 Seconds
Test Strip Volume: 1.2 µL
Test Methodology: Electrochemistry


Sample Types & Operating Modes:
Whole Blood: Arterial, Venous, Capillary, Neonatal


Glucose Measurement Range: 10-600 mg/dL (0.6-33.3 mmol/L)


Interferences (Measured and Corrected for):
Hematocrit, Ascorbic Acid, Uric Acid, Acetaminophen (Paracetamol), Bilirubin, Maltose, Galactose, Oxygen


Operating Ranges:
Temperature: 15°C- 40°C (59°F-104°F)
Altitude: Up to 15,000 feet
Humidity: 10% to 90% relative humidity


Reagents and Strips:
Strips: Cases of 36 vials (1,800 strips); vials packaged 50 strips/vial
QC: Three levels (Low, Normal, High); sold separately
Linearity: Five levels available


Test Strip Stability:
24 months from date of manufacturing in USA
180-day open-vial stability


QC Stability:
24 months from date of manufacturing
90-day open-vial stability