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LABiTec GmbH, CoaData 2004 and 4004 (Coagulation 2019)

LABiTec GmbH, CoaData 2004 and 4004 (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

LABiTec GmbH
Matthias Schramm
Ahrensburg, Germany

Instrument name/First year sold CoaData 2004 and 4004/—
Number of units installed in U.S./Outside U.S. —/>500
Number of contracts signed between 1/1/18 and 11/15/18
Country where analyzer designed/Manufactured Germany/Germany
Operational type discrete
Reagent type open reagent system
Operates on whole blood or spun plasma spun plasma
Sample handling system semiautomated manual pipette, auto start
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 3.54 × 10.24 × 12.99 in./8.6 lbs./2 sq. ft.
FDA-cleared clotting-based tests
FDA-cleared chromogenic tests
FDA-cleared immunologic tests
Other FDA-cleared tests
User-defined tests in clinical use
Tests submitted for 510(k) clearance
Tests in development but not yet submitted
Methodologies supported LED photometer (2 wavelengths per channel) incl. mixing; supports coagulation, chromogenic, and immunologic assays
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 1
Number of different assays programmed and calib. at one time 15
Number of user-definable (open) channels 8
Of those defined, number active simultaneously 1
Factor assays require manual manipulation or dilutions yes
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 4/reagent manufacturer defined/no
Multiple reagent configurations supported yes
Reagents, consumables loaded without interrupting testing yes
Same capabilities when third-party reagent used yes
Maximum time same lot number of reagents can be used reagent manufacturer defined
Walkaway capacity: Number of specimens/Number of tests 16/18 incubational positions
Minimum sample volume aspirated precisely at one time 50 µL (150 µL total volume)
Standard specimen volume required to run PT or PTT/ Factor VIII activity 50 µL/—
Disposables used/Price of each micro single cuvette, printer paper/—
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes no/no
Sample/Reagent barcode reading capability optional/no
Onboard test automatic inventory no
Measures No. of tests remaining/Short sample detection no/no
Clot detection as preanalytical variable in plasma sample no
Auto. detects adequate reagents for aspiration and analysis no
Hemolysis/Turbidity detection-quantitation no/no
Dilution of patient samples onboard no
Automatic rerun capability/Auto reflex testing capability no/no
Lag time during which hypercoagulable sample not detected no
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
• Fibrinogen
• Factor VIII activity assay
Time delay from ordering stat to aspiration of sample
Automatic transfer of QC results to LIS no
Data-management capability no
Interface supplied by instrument vendor no
Interfaces in active user sites for:
Bidirectional interface capability no
Results transferred to LIS as soon as test time complete yes (unidirectional interface)
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 no
Modem servicing no
Time required for maintenance by lab personnel per shift: <1 minute (cleaning housing); daily: <1 minute (cleaning housing); weekly: <5 minutes (cleaning housing and incubating block)
Onboard maintenance records no
Training provided with purchase 1 day, on request
Approximate number of training hours needed per tech 4
List price
Annual service contract cost (24/7)/Warranty with purchase —/1 year
Distinguishing features (supplied by company) price-competitive 2-channel (CoaDATA 2004) and 4-channel (CoaDATA 4004) new generation; photometer optics provide 2 wavelengths on each measuring channel including mechanical stirring (HIL optimized); low maintenance and repair costs
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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