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Nova Biomedical, StatStrip Glucose Hospital Monitoring System (BedsideGlucose_2018)

Nova Biomedical, StatStrip Glucose Hospital Monitoring System (BedsideGlucose_2018)

Bedside glucose testing systems, April 2018

Contact Information


Nova Biomedical

Nova Sales
info@novabio.com
Waltham, MA
781-894-0800 or 800-458-5813



Name of instrument/First year sold StatStrip Glucose Hospital Monitoring System/2006
Professional or home use professional
Total units sold in U.S./Total units sold outside U.S.
No. of contracts for product signed in 2017
Dimensions (H × W × D)/Weight 5.8 × 3.1 × 1.18 in/0.49 lb (220 g)
Analytical method or technology or enzyme system used electrochemical
No. of disposable reagent system units per basic package 50 test strips per vial
Disposable units shelf life/Reagent unit storage requirements 24 months from date of manufacture/room temperature
Digital readout character size/Keypad input capability variable, defined by the particular field or menu/menu selection, numeric, alphabetic
How results are displayed plasma equivalent values
Specimen types/Sampling techniques whole blood/drop
Minimum specimen volume required 1.2 µL
Suitable for samples from well neonates/Sick neonates yes/yes
Time from sample introduction to result availability 6 seconds
Batteries used/No. used/Average life of one set of batteries 3.7v Li-polymer (rechargeable/replaceable)/1/24–36 months
Average expected life of device/Mean time between failures 5+ years/—
Device warranty/Service options/Loaners provided 2 years (optional 5-year extended warranty)/meter replacement/yes
User list or user group no
Toll-free No. for customer questions/Hours of operation 800-458-5813/24 hours, 7 days, all year
Training and certification program/No. of training days provided yes/defined during implementation planning
Average time for lab to complete maintenance no user maintenance required
Internal QC recommended or required CLIA requirements, two levels per day or per hospital policy
Between instrument CV (based on PT) at the following glucose levels:
• <50 mg/dL
• 100–200 mg/dL
• >400 mg/dL
• Program name, year/Challenge No./Level of mean glucose challenge sample
Accuracy/Compared with what reference method or device >97% versus IDMS-traceable laboratory reference method/tested to CLSI POCT 12-A3 criteria (r2=0.994)
Precision/Compared with what reference method or device within run=1.9–3.6% (whole blood) and day to day=3.4–4.7% (linearity standards)/—
Linear range 10–600 mg/dL (0.5–33.3 mmol/L)
Suggested dynamic or measurement range 10–600 mg/dL (0.5–33.3 mmol/L)
Contraindications no
Known interferences/High-altitude interference none/none, up to 15,000 feet
Restrictions based on hematocrit no
Electronic and optical function checks electronic checks for out-of-range glucose results, dosing, out-of-range Hct results
Sample quantity checks RapidFill sampling electronically checks for correct strip dosing
When auto lock or shutdown occurs user ID failure, QC failure, required docking for data transfer (if configured)
User defines QC lockout intervals/QC lockout can be circumvented yes/no
Information for which device supports barcode scanning operator ID, patient ID, reagent lot No., QC lots
Method of analyst ID/ID required barcode scan or virtual keypad input/required
Internal memory size/Maximum No. of patient results stored 1,000 patient samples, 200 QC samples, 4,000 operators/1,000 patient samples
Meter connections for information transfer data-management system, which in turn connects to LIS/HIS
How meters are connected to external system to upload results hospital network, real-time wireless (RF Nova)
Information contained in transmission to external system device unique identifier, operator ID, patient ID, result, QC identifier
Hardware/software for data-management system connects to Telcor QML, RALS, RALS Plus, RALS Freedom, Orchard Trellis, Conworx POCellerator
No. of different management reports system can produce provided by middleware
Contents downloaded from DMS to meter strip lot numbers, valid control values, valid operator IDs, patient demographics (with ADT interface), configuration files, physician ID, diagnostic codes, physician notes
LISs/HISs to which system is connected (live installs) using:
• Screen animation/Screen scraping
• Standard HL7 interface
• Proprietary protocol interface
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces yes, Telcor QML, RALS Freedom, RALS Plus
LOINC can be used to identify tests when communicating with LIS yes
Distinguishing features (supplied by company) FDA cleared for use with critically ill patients; measures and eliminates interferences from hematocrit, oxygen, acetaminophen, ascorbic acid, uric acid, and other electrochemical substances; no interference from maltose, galactose, or xylose; unlimited manual test entry; CLIA waived for use with all patients, in all departments
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.