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Roche Diagnostics, Accu-Chek Performa System (BedsideGlucose_2018)

Roche Diagnostics, Accu-Chek Performa System (BedsideGlucose_2018)

Bedside glucose testing systems, April 2018

Contact Information

Roche Diagnostics
Accu-Chek Customer Care Service Center
Indianapolis, IN

Name of instrument/First year sold Accu-Chek Performa System/2013
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 22 x 52 x 93 mm/62 g
Analytical method or technology or enzyme system used electrochemical (AC/DC), mutant variant quinoprotein glucose dehydrogenase
No. of disposable reagent system units per basic package 50 strips per vial
Disposable units shelf life/Reagent unit storage requirements 18 months/39°–86°F (4°–30°C)
Digital readout character size/Keypad input capability —/numeric, alphabetic
How results are displayed plasma equivalent values
Specimen types/Sampling techniques fresh capillary, venous, arterial, whole blood/drop
Minimum specimen volume required 0.6 µL
Suitable for samples from well neonates/Sick neonates no/no
Time from sample introduction to result availability 5 seconds
Batteries used/No. used/Average life of one set of batteries 3v lithium (type CR2032)/1/2,000 tests
Average expected life of device/Mean time between failures
Device warranty/Service options/Loaners provided
User list or user group no
Toll-free No. for customer questions/Hours of operation 800-440-3638/24 hours, 7 days, all year
Training and certification program/No. of training days provided yes/—
Average time for lab to complete maintenance
Internal QC recommended or required follow facility policy for control testing intervals
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 —/hexokinase method traceable to NIST
Precision/Compared with what reference method or device —/hexokinase method traceable to NIST
Linear range 20–600 mg/dL
Suggested dynamic or measurement range 20–600 mg/dL
Contraindications yes, per labeling
Known interferences/High-altitude interference per labeling/none, up to 10,000 feet
Restrictions based on hematocrit yes, 10–65%
Electronic and optical function checks 150 integrity checks, including variation in hematocrit, temperature, and humidity
Sample quantity checks sampling checked electronically for complete sample dosing
When auto lock or shutdown occurs
User defines QC lockout intervals/QC lockout can be circumvented no/no
Information for which device supports barcode scanning
Method of analyst ID/ID required
Internal memory size/Maximum No. of patient results stored 20 controls, 300 glucose results/300
Meter connections for information transfer
How meters are connected to external system to upload results
Information contained in transmission to external system
Hardware/software for data-management system
No. of different management reports system can produce
Contents downloaded from DMS to meter
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
LOINC can be used to identify tests when communicating with LIS
Distinguishing features (supplied by company) handheld meter cleared for multipatient use; easy-to-use technology provides automatic system, strip, and integrity checks; accurate results in 5 seconds with only 0.6 µL sample size; small, sleek design with a large, easy-to-read display
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.