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| Name of instrument/First year sold | Glucose 201 Analyzer/2002 |
| Professional or home use | professional |
| Total units sold in U.S./Total units sold outside U.S. | — |
| No. of contracts for product signed in 2012 | — |
| Dimensions (H × W × D)/Weight | 6.3 × 3.4 × 1.7 in/0.77 lbs |
| Analytical method or technology or enzyme system used | absorbance photometry, glucose dehydrogenase |
| No. of disposable reagent system units per basic package | 25 in vial/box; four vials/boxes per package |
| Disposable units shelf life/Reagent unit storage requirements | 9 months from manufacture date/refrigeration |
| Digital readout character size/Keypad input capability | 0.5 in/none |
| How results are displayed | plasma equivalent values |
| Specimen types/Sampling techniques | whole blood, venous, capillary, or arterial/exact amount of blood is drawn into the cuvette by capillary force |
| Minimum specimen volume required | 5 µL |
| Suitable for samples from well neonates/Sick neonates | yes/yes |
| Time from sample introduction to result availability | 40–240 seconds |
| Batteries used/No. used/Average life of one set of batteries | AA/4/150 hours |
| Average expected life of device/Mean time between failures | 7 years/>5 years |
| Device warranty/Service options/Loaners provided | 2 years at no extra cost/—/yes |
| User list or user group | no |
| Toll-free No. for customer questions/Hours of operation | 800-323-1674, 6 am–5 pm PST |
| Training & certification program/No. of training days provided | yes/as needed |
| Average time for lab to complete maintenance | daily: ≤5 minutes |
| Internal QC recommended or required | as specified by accreditation |
| Between instrument CV (based on PT) at the following glucose levels: | |
| • <50 mg/dL | not available |
| • 100–200 mg/dL | 3.8 |
| • >400 mg/dL | ≥272 mg/dL=2.9 |
| • Program name, year/Challenge No./Level of mean glucose challenge sample | Equalis (Swedish PT program), 2003/2003-03; 2003-07/272 mg/dL; 120 mg/dL |
| Accuracy/Compared to what reference method or device | ±10% or ±6 mg/dL; corr=0.994/wet chemical glucose dehydrogenase, ID-GCMS |
| Precision/Compared to what reference method or device | within run CV 1.9 percent (108 mg/dL)/— |
| Linear range | 0–444 mg/dL |
| Suggested dynamic or measurement range | 0–444 mg/dL |
| Contraindications | no |
| Known interferences/High-altitude interference | grossly lipemic samples, methemoglobin, glucosamine/no |
| Restrictions based on hematocrit | no |
| Electronic and optical function checks | internal electronic self-test automatically checks that the instrument’s optronic unit is working properly |
| Sample quantity checks | visual inspection |
| When auto lock or shutdown occurs | — |
| User defines QC lockout intervals/QC lockout can be circumvented | no/no |
| Information for which device supports bar-code scanning | no bar-code scanner |
| Method of analyst identification/Identification required | — |
| Internal memory size/Maximum No. of patient results stored | — |
| 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) | CLIA-waived; indicated for diagnosis of diabetes mellitus; not hematocrit-dependent; lab verification of patient home meter; no interference from maltose or galactose; no need to recalibrate |
| 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. |
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