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LABiTec GmbH, CoaLAB 1000 (Coagulation 2019)

LABiTec GmbH, CoaLAB 1000 (Coagulation 2019)

Coagulation analyzers, January 2019

Contact Information

LABiTec GmbH
Matthias Schramm
Ahrensburg, Germany

Instrument name/First year sold CoaLAB 1000/2009
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 batch, random access
Reagent type open reagent system (reconstituted manually)
Operates on whole blood or spun plasma spun plasma
Sample handling system two fixed racks of 11 samples each plus 3 stat
Model type benchtop
Dimensions (H × W × D)/Weight/Instrument footprint 30.7 × 22.9 × 19.6 in./55.1 lbs./—
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 optical, turbidimetric for clot detection, immunologic, chromogenic, and aggregation tests
Operator must load sep. reagent pack per specimen/Test run no/no
Number of different measured assays onboard simultaneously 15 maximum
Number of different assays programmed and calib. at one time 50
Number of user-definable (open) channels 2
Of those defined, number active simultaneously 2
Factor assays require manual manipulation or dilutions no
Number of reagent containers onboard at once/Tests per container/Reagents refrigerated onboard 15/200 maximum/no
Multiple reagent configurations supported yes
Reagents, consumables loaded without interrupting testing 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 25 maximum/>10
Minimum sample volume aspirated precisely at one time 2 µL
Standard specimen volume required to run PT or PTT/ Factor VIII activity PT: 100 µL reagent, 50 µL sample; APTT: 50 µL reagent, 50 µL sample, 50 µL CACl2/50 µL APTT, 50 µL deficient plasma, 50 µL sample, 50 µL CACl2
Disposables used/Price of each cuvette ring (32 single cuvettes per ring), sample cups/—
Supports direct-from-track sampling no
Primary tube sampling supported/Pierces caps on primary tubes yes (1.7–4 mL)/no
Sample/Reagent barcode reading capability yes/no
Onboard test automatic inventory yes
Measures No. of tests remaining/Short sample detection yes/yes
Clot detection as preanalytical variable in plasma sample yes
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/no
Lag time during which hypercoagulable sample not detected yes (PT: <10 seconds; PTT: <20 seconds)
Read time extended for prolonged clotting times yes
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 yes/yes
Auto shutdown/Auto startup programmable no/no
Stat time to complete all analytes/Throughput per hour for:
• PT alone <2 minutes/120 specimens
• PT, PTT <5 minutes/71 specimens
• Fibrinogen <5 minutes/50 specimens
• Factor VIII activity assay depends on assay
Time delay from ordering stat to aspiration of sample 3 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 yes (included)
Interfaces in active user sites for: via LAN, Windows OS, Linux OS
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 no
Modem servicing no
Time required for maintenance by lab personnel per shift: <1 minute; daily: 3 minutes; weekly: 5 minutes; monthly: calibration 15 minutes
Onboard maintenance records no
Training provided with purchase 3 days at vendor offices, on site on request
Approximate number of training hours needed per tech
List price
Annual service contract cost (24/7)/Warranty with purchase —/1 year
Distinguishing features (supplied by company) standalone device, requires no additional PC monitor to control, onboard software, only external printer; flexible and extendable by software add-ons; different wavelength available; optimized for small to mid-size labs; special hemostasis of diagnostic assays
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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