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Roche Diagnostics, cobas u 411 analyzer (Urinalysis 2017)

Roche Diagnostics, cobas u 411 analyzer (Urinalysis 2017)

Urinalysis instrumentation, December 2017

Contact Information

Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250

Name of urinalysis instrument cobas u 411 analyzer
Type of instrument urine chemistry
First year instrument sold in U.S. 2006
No. of units installed in U.S./No. of units installed outside U.S. >400/>2,300
Intended urine sample volume per day 40–100
Dimensions (HxWxD)/Weight 10.24 × 16.73 × 13.34 in./26 lbs.
Power requirements 110 VAC
Mean time between failure of instrument >365 days
Events that cause instrument to lock or stop analysis opening front cover
Urine chemistry: (Information in this box is specific to urine chemistry)
• Testing methodology: Specific gravity/Color/Clarity test strip/test strip/visual detection
• Urine chemistry tests available on instrument bilirubin, glucose, ketone, leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen
• Color compensation pad included
• Flagging thresholds customizable
• Test strip configuration loosely packed in bottles
• Calibration required after each test strip lot No. change yes
• Frequency of customer-performed calibration monthly
• Form of calibration dry
• How results are displayed for urine chemistry semiquantitative
• Reporting format customizable yes
• No. of sample results/Control results that can be held in internal memory 1,000/900
Microscopy/sediment: (Information in this box is specific to microscopy/sediment)
• Microscopy/sediment technology
• Microscopy/sediment analysis parameters
• Instrument eliminates amorphous crystal interference before sample analysis
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of sample results/Control results that can be held in internal memory
Reagent shelf-life and storage temperature for unopened containers 2–30°C
Reagent shelf-life and storage temperature for opened containers 2–30°C
Reagent barcode-reading capability yes
How often quality control samples are run minimum of daily
Sample throughput per hour/Time to first result 600/—
Analyzer has stat mode yes (minimum sample volume is ­minimum amount necessary to immerse pads)
Sample dilutions required for urinalysis no
Sample dilutions required for body fluid analysis no
Special sample handling required for body fluid analysis no
Minimum width of sample tube/Minimum height of sample tube
Conditions or substances that prevent sample from being run preservatives
Means of sample ID entry barcode scan, bidirectional download from host, worklist download from host, manual entry
Built-in liquid-level sensing for samples no
Information that can be barcode scanned on instrument specimen identifier
How LOINC codes for results are made available website, e-mail query
Software includes reflex testing functionality no
Software includes cross-check functionality no
Instrument automatically generates consolidated report* no
Instrument connections to transfer information data-management system, which connects to LIS/EHR, or directly to LIS/EHR/lab automation system, or via commercial middleware
Interface standards supported ASTM 1394-91, ASTM 1238-95
Connection to LIS or EHR to upload patient and QC results direct serial
Information included in transmission from instrument to data-management software specimen ID, result
No. of days of on-site training with purchase 0
No. of days of training at vendor office 0
Approximate scheduled maintenance time required 5 min. daily; 10 min. monthly
Instrument list price $13,500
Cost of annual service contract/Length of warranty —/1 year
Provide list of client sites to potential customers on request no (information is confidential)
Clients restricted from sharing their experience with company or software no
Distinguishing instrument features (supplied by company) • fast, efficient processing of urine strips; analyzer ready to test every six seconds • Chemstrip 10UA strip has virtually no interference with ascorbic acid, minimizing false-negative glucose results • flexible sample ID entry options let user choose barcode scan, download from host, or manual entry options
*chemistry and microscopy results in one report
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.