StatStrip® and StatStrip Xpress®2 Glucose Meters



StatStrip Glucose Hospital Meter System Receives FDA Clearance for Capillary Testing with Critically Ill Patients

Only glucose meters with FDA clearance for use with ALL patients including critically ill

CLIA waived for use with arterial, venous, and capillary samples from critically ill patients

ONLY glucose meter with no known clinical interferences—over 8,000 medications tested

  • Measures and corrects for interferences, which cause incorrect glucose results in other meters and patient mismanagement

Proven safety and accuracy

  • In one study of over 17,300 capillary results from critically ill patients that were compared to lab results
  • In another study of 1,698 arterial and venous results from critically ill patients with over 257 medical conditions were compared to lab results
  • 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 by the FDA and high complexity testing under CLIA

 

 

Read Nova’s 2018 press release for StatStrip’s capillary
critical care clearance here

Read the FDA’s 2014 press release for StatStrip’s
critical care clearance here

Read Nova’s 2014 press release for StatStrip here
Read the StatStrip® Glucose Published Evaluations here

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 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, 168 other independent studies over the last eight years—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

Learn more

To learn more about how StatStrip can help hospitals avoid the risk of glucose meter off-label use and bring critical care testing to the bedside, call Nova at 800-458-5813, or contact us here

For more general product information, click here or contact Nova Biomedical at: Nova Biomedical / 200 Prospect Street / Waltham, MA 02454 / 781-894-0800

Specifications


StatStrip Glucose Connectivity Meter

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
QC Tests: 200 tests
Users: 8,000 users


Connectivity:

Meter Data Output: RJ-45 Ethernet Port
Protocol: TCP/IP Ethernet 10 Mbit
Standard: POCT1-A2 Compliant
Setup Program: NovaNet™ Web-Based Instrument Manager Software

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:

Optional accessory; desk or wall mount charging station with RJ-45 Ethernet jack. 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:

  • Color touchscreen
  • Built-in 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
  • Canned or free text user comments
  • Reject results at meter (optional) for repeat testing
  • Accept patient ID or accession number
  • Use of operator password (lockout)
  • Entry of offline tests
  • Entry of ICD-9 diagnosis codes
  • Order physician ID
  • Onscreen training mode
  • Correlation mode
  • Slope and intercept adjustment
  • Web-based meter configuration by location
  • Custom meter configuration by medical unit
  • Connect to hospital ADT
  • Connect to all LIS/EMR
  • POCT1-A2 data output

 

 

 


StatStrip Xpress2 Glucose Meter

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: 3V Li Button Battery
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

Certifications and Compliance: Nova Biomedical complies with the FDA Quality Systems Regulations and is certified to EN ISO 13485:2016. Complies to IVDD. Tested according to: EN 61010-1:2010, EN 61010-2-101:2015, EN 60825-1/A1:2014. Certifications and compliances applicable in countries where regulations require.

Specifications current as of revision date.