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Siemens Healthcare Diagnostics, Sysmex CA-1500 (Coagulation 2013)

Siemens Healthcare Diagnostics, Sysmex CA-1500 (Coagulation 2013)

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Contact Information

Siemens Healthcare Diagnostics
Jackie Hauser
jacqueline.k.hauser@siemens.com
511 Benedict Ave.
Tarrytown, NY 10591
847-267-5383


Instrument name/First year sold Sysmex CA-1500/U.S.: 2000; worldwide: 1999
Number of units installed in U.S./Outside U.S.
Number of contracts signed between 1/1/12 and 11/30/12
Country where analyzer designed/Manufactured Japan/Japan
Operational type continuous random access
Reagent type open reagent system (lyophilized, reconstituted manually), optimized for Siemens instruments
Operates on whole blood or spun plasma spun plasma
Sample handling system 10-tube position sample rack × 5
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 20 × 31.2 × 31.2 inches/186 lbs/6.8 square feet
FDA-cleared clotting-based tests PT, APTT, fibrinogen, TT, reptilase time, factor assays, DRVVT screen and confirm, factor V Leiden, protein C clot, protein S activity
FDA-cleared chromogenic tests Innovance AT, Berichrom AT, plasminogen, factor VIII chromo, alpha-2 antiplasmin, protein C chromo, heparin
FDA-cleared immunologic tests Innovance D-dimer
Other FDA-cleared tests
User-defined tests in clinical use
Tests submitted for 510(k) clearance PT multi-calibrators, innovance VWF activity assay
Tests in development but not yet submitted
Methodologies supported clot detection, optical, turbidimetric; chromogenic; immunologic
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 15
Number of different assays programmed and calib. at one time 25
Number of user-definable (open) channels 25
Of those defined, number active simultaneously 15
Factor assays require manual manipulation or dilutions no
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 39/up to 200/yes (15°C)
Multiple reagent configurations supported yes
Reagents, consumables loaded without interrupting testing some consumables yes, reagents no
Same capabilities when third-party reagent used yes
Maximum time same lot number of reagents can be used 1 year
Walkaway capacity: Number of specimens/Number of tests 50/up to 1,000
Minimum sample volume aspirated precisely at one time 5 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity 50 µL/5 µL
Disposables used/Price of each reaction tubes, sample plates, CA clean I and II, system buffer, halogen lamp, closed container sample replacement needles/varies with volume
Supports direct-from-track sampling yes (Sysmex CST series)
Primary tube sampling supported/Pierces caps on primary tubes yes (3–5 mL)/yes
Sample bar-code reading capability yes
Reagent bar-code reading capability yes
Onboard test automatic inventory yes
Measures No. of tests remaining/Short sample detection yes/yes
Clot detection as preanalytical variable in plasma sample no
Auto. detects adequate reagents for aspiration and analysis yes
Hemolysis/Turbidity detection-quantitation no/yes
Dilution of patient samples onboard yes
Automatic rerun capability/Auto reflex testing capability yes/yes
Lag time during which hypercoagulable sample not detected yes (PT: 7 seconds, APTT: 15 seconds)
Read time extended for prolonged clotting times yes (selectable on menus)
User can set different-than-standard:
• Reagent volumes/Sample volumes yes/yes
• No. and sources of reagent yes
• Incubation times/Reading times yes/yes
Autocalib. or autocalib. alert/Multipoint calib. supported no/yes
Auto shutdown/Auto startup programmable no/no
Stat time to complete all analytes/Throughput per hour for:
• PT alone 7 minutes/120 results
• PT, PTT 8 minutes/80 results
• Fibrinogen 8 minutes/120 results
• Factor VIII activity assay 8 minutes/—
Time delay from ordering stat to aspiration of sample 2 minutes
Automatic transfer of QC results to LIS yes
Data-management capability onboard (includes QC: L-J plots and Westgard Multirules)
Interface supplied by instrument vendor no
Interfaces in active user sites for: all major LIS vendors
Bidirectional interface capability yes (host query)
Results transferred to LIS as soon as test time complete yes
LOINC codes transmitted with all results no
How labs get LOINC codes for reagent kits
Electronic interface available (or will be) to automated (or robotic) specimen handling system yes (Sysmex CST series)
Modem servicing no
Time required for maintenance by lab personnel daily: <5 minutes; weekly: 1 minute; quarterly: <5 minutes
Onboard maintenance records no
Training provided with purchase 3 days at vendor offices for key operator, online training course, Web CD training
Approximate number of training hours needed per tech 6
List price $97,529 standard model; $110,544 cap-piercing model
Annual service contract cost (24/7)/Warranty with purchase
Distinguishing features (supplied by company) simultaneous curve calibrating and patient testing; ability to load multiple bottles or multiple lots of reagent; user-definable, repeat, redilute, and reflex testing
Tabulation does not represent an endorsement by the College of American Pathologists.