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Abbott Point of Care, i-STAT System

Abbott Point of Care, i-STAT System

In vitro blood gas analyzers, May 2017

Contact Information

Abbott Point of Care

Jeff Abney
400 College Rd. East
Princeton, NJ 08540

Name of device/First year sold/Number of analyzers sold in 2016 i-STAT System/1992/—
Number of devices sold in U.S./Outside U.S./List price 30,000+/20,000+/$13,924.05
Dimensions (H x W x D)/Weight 9.25 × 3 × 2.85 inches/22.4 ounces
Analytes measured on device pH, pCO2, pO2, Hct, Na, K, Cl, iCa, lactate, glucose, creatinine, BUN, TCO2, cTnl, CK-MB, BNP, ACT, PT/INR
Parameters calculated on device Hb, Hct, O2SAT, BE, TCO2, HCO3
Barometric pressure measured
Analytical method(s) or technologies employed electrochemical for all analytes
Device is part of a series of related models no
Device warranty/Loaner devices provided 1 year replacement/—
Average life expectancy of device 8 years
Open or closed system/External gas tanks required closed/no
Categorized for point-of-care testing or laboratory point-of-care testing
Point of care:
Disposable prepackaged system used for analysis reagent, electrode (single use)
No. of disposable reagent system units in standard package 25
No. of samples analyzed per one disposable reagent, electrode system 1
Reagent unit storage requirements refrigerate: 2-month shelf life for blood gas cartridges, 2-week shelf life for all others
Shelf life of disposable units up to 6 months
No. of different disposable reagents required to maintain device
Max. No. of analyte reagents that can reside in device at once
Shelf life of components
Cost per test/Reagent cost per test
Calibrations required 1 point (automatic)
Calibration frequency every test
Internal QC program recommended electronic QC, automated internal wet QC
QC features/Capabilities of QC features comparable plot/monthly cumulative reports (available with external system)
Remote control of device from laboratory yes
System can use LOINC to transmit results to LIS no
Specimen types suitable for device whole blood, capillary, mixed venous, arterial, venous
Acceptable anticoagulants/Sampling technique heparin/injection, capillary transfer and fill
Sample size for complete panel of analyte results 96 µL blood gas, 65 µL electrolytes
Sample size differs with number of analytes selected no
Time from sample introduction to result availability ~2 minutes
Max. No. of patient samples per hour/Max. No. measured results per hour 20 per unit/160
Optimal throughput when analyzer calibrated, awaiting specimens
Calibration can be interrupted to perform stat sample
Known interferences
Sampler has self-wiping probe
Time required for maintenance by lab personnel
Service center performs diagnostics through modem yes
Method of analyst ID in system keypad entry/barcode scanner (customizable)
Instrument response for:
• hardware failure/software failure code number error message/code number error message
• QC failure code number error message
• calibration failure code number error message
For what barcode scanning is provided operator and patient IDs, reagent lot number
Built-in printer/Data port no/—
Information listed on hard copy report device-unique identifier, operator and patient IDs, results, QC results, QC identifier
Analyzer connections LIS/HIS, via data-management system
Interface standards supported ASTM 1394 and 1238, HL7
How analyzer connects to external system to upload patient and QC results hospital Ethernet or wireless network
Information included in transmission from analyzer to external system device-unique identifier, operator and patient IDs, results, QC identifier, others
Hardware and software for data-management system PrecisionWeb, Central Data Station
No. of different management reports system produces 35+
Contents downloaded from data-management system to analyzer valid operator IDs, device behavior customizations
System connected (live installations) to which LISs, HISs major LIS vendors
Use a third-party interfacing tool, engine for LIS, HIS interfaces yes, Sybase Interface Manager
Distinguishing features (supplied by company) handheld, portable, single-use test cartridge menu; broad test menu; laboratory-accurate results at the bedside; integrated 802.11b or g bidirectional data transmission to data manager
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.