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| Instrument name | INRatio/INRatio2 PT INR Monitoring System |
| First year sold | 2003 (INRatio)/2008 (INRatio2) |
| No. of units sold in U.S./Outside U.S. | — |
| No. of units sold in 2012 | — |
| • units sold to: | — |
| Country where analyzer designed/Manufactured | U.S./U.S. |
| Is instrument POC or self-monitoring analyzer? | POC and self-monitoring analyzer |
| Specimen type | fingerstick |
| Model type | handheld/portable |
| Dimensions in inches (H × W × D)/Weight | 5.9 × 2.9 × 1.8/9.3 oz with batteries |
| Specimen volume needs | accurate volume not necessary (drop) ~15 µL |
| Clotting-based tests for which device has FDA-cleared applications | PT (reportable range: low 7 seconds, high 75 seconds; INR: low 0.7, high 7.5) |
| 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 | electrochemical detection, change in impedance as sample clots |
| Quality control methods | |
| • Electronic | no (not required, built-in two-level QC on each strip) |
| • Liquid | no (not required, built-in two-level QC on each strip) |
| • Lyophilized | no |
| • Integrated QC with each analysis | yes |
| • Automatic lockout for QC failure | yes |
| • Other | — |
| 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 | yes |
| LOINC codes transmitted with results | — |
| How labs get LOINC codes for reagent kit | — |
| Commercially available systems for which interfaces are up and running in active user sites | Alere CoagClinic and PC Connect |
| 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, for sample (volume), reagent stability |
| Training provided with instrument purchase | yes (on site) |
| Approximate number of training hours needed for: | |
| • Medical staff | 1 |
| • Patient | 1 |
| Patient self-testing program is available | yes |
| Instrument list price | $1,595 professional; $1,995 self-test |
| Reagent rental or lease only | no |
| Cost per sample for: | |
| • PT: Cost per sample for reagent rental | volume-dependent |
| 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 | CLIA waived |
| Distinguishing features (supplied by company) | onboard QC—two levels of quantitative controls with reportable results; individually wrapped, nonrefrigerated test strips; one-drop fingerstick sample; 12-month dating on test strips; 120-test memory, including QC values; simple three-step test process; human recombinant thromboplastin (ISI 1.0) |
| 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. |