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| Instrument name | CoaguChek XS Pro PT Test System |
| First year sold | 2010 |
| No. of units sold in U.S./Outside U.S. | —/— |
| No. of units sold in 2012 | — |
| • units sold to: | — |
| Country where analyzer designed/Manufactured | Germany/Germany |
| Is instrument POC or self-monitoring analyzer? | POC |
| Specimen type | fresh whole blood (venous or fingerstick capillary) |
| Model type | handheld/portable |
| Dimensions in inches (H × W × D)/Weight | 9.09 × 3.89 × 1.65/350 g |
| Specimen volume needs | 8 µL |
| Clotting-based tests for which device has FDA-cleared applications | PT (reportable range: low 9.6 seconds, high 96 seconds; INR: low 0.8 seconds, high 8.0 seconds) |
| Tests using other methodologies for which device has FDA-cleared applications | — |
| FDA-cleared tests but not yet clinically released | — |
| Tests submitted for 510(k) clearance | — |
| Tests in development but not yet submitted for clearance | — |
| Method of endpoint detection | amperometric detection |
| Quality control methods | |
| • Electronic | no (not required, onboard QC) |
| • Liquid | yes (available as an option but not required due to onboard controls) |
| • Lyophilized | no |
| • Integrated QC with each analysis | yes |
| • Automatic lockout for QC failure | yes |
| • Other | optional operator lockout |
| Time (in minutes) to perform control plus specimen test | |
| • PT: | <1 |
| • PT and PTT: | — |
| • ACT: | — |
| Data-management capability | yes |
| Includes QC | yes |
| System can automatically transfer data to information system | |
| • Patient data | yes |
| • QC data | yes |
| Interface supplied by instrument vendor | POCT1-A |
| LOINC codes transmitted with results | no |
| How labs get LOINC codes for reagent kit | — |
| Commercially available systems for which interfaces are up and running in active user sites | RALS-Plus |
| Lab can control analyzer remotely | no |
| Real-time wireless linkage to LIS or HIS | no |
| Positive identification system (e.g. bar code) for: | |
| • Patient specimen | no |
| • Reagent | no |
| Onboard system for automatic error detection | yes |
| Training provided with instrument purchase | yes (on site) |
| Approximate number of training hours needed for: | |
| • Medical staff | 1.5 |
| • Patient | — |
| Patient self-testing program is available | no |
| Instrument list price | — |
| Reagent rental or lease only | no |
| Cost per sample for: | |
| • PT: Cost per sample for reagent rental | — |
| Cost per sample if device purchased | — |
| • PTT: Cost per sample for reagent rental | — |
| Cost per sample if device purchased | — |
| • ACT: Cost per sample for reagent rental | — |
| Cost per sample if device purchased | — |
| CLIA ’88 complexity rating | moderate |
| Distinguishing features (supplied by company) | performs onboard quality control and determines patient results in a single test chamber; neutralizes therapeutic levels of heparin and LMWH; INR corrected for hematocrit within specified range; 21-month strip shelf life, no refrigeration needed; top or side dosing; results in one minute or less; icon-driven color screen interface, memory of 2,000 patient and 500 optional liquid QC tests, ability to add comments with each patient and liquid quality control test; integrated bar-code scanner able to scan operator and patient IDs |
| 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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