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Ortho-Clinical Diagnostics, VITROS 5600 Integrated System (Chemistry 2013)

Ortho-Clinical Diagnostics, VITROS 5600 Integrated System (Chemistry 2013)

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Contact Information

Chemistry analyzer for high-volume laboratory
Ortho-Clinical Diagnostics
Mark Steelman
msteelma@its.jnj.com
1001 U.S. Route 202
Raritan, NJ 08869
585-453-3420


Name of instrument/First year sold in U.S. VITROS 5600 Integrated System/2008
List price/Total No. sold in 2012 $410,000/—
Number of units in clinical use in U.S./Outside U.S. >1,400/worldwide
Where designed/Manufactured/Where reagents manufactured U.S./U.S./U.S. and United Kingdom
Operational type/Reagent type batch, random access, discrete, continuous random access/self-contained multi-use cartridges, packages, slides
Sample handling system/Model type universal sample tray/floor standing
Dimensions in inches (H x W x D)/Footprint in square feet 68 × 110 × 34.9/26.7
Number of tests for which analyzer has FDA-cleared applications >110
Tests released for clinical use in last 12 months vitamin D
Tests cleared but not released for clinical use
Tests not available in U.S. but submitted for 510(k) clearance
Tests not available in U.S. but available in other countries rub IgM, tox IgG, tox IgM, CMV IgG, CMV IgM, syphilis, free PSA, and total PSA II
Research-use-only assays
Tests in development
Methodologies supported/immunoassay methodologies photometry, potentiometry (ISE), thin film reflectance/homogeneous EMIT, microparticle agglutination, enhanced chemiluminescence
Number of direct ion-selective electrode channels 3
Number of different measured assays onboard simultaneously 150
Number of different assays programmed and calibrated at once 150
Number of user-definable (open) channels/Number active simultaneously 20/10
Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set 150/100
Shortest/Median onboard reagent stability/Refrigerated onboard 48 hours/30 days/yes (2°–8°C)
Multiple reagent configurations supported yes
Reagent container placed directly on system for use yes
Instrument has same capabilities when third-party reagents used yes
Walkaway capacity in minutes/Specimens/Tests or assays varies/90/11,440
Uses disposable cuvettes/Maximum number stored yes/348
Uses washable cuvettes/Replacement frequency no/—
Minimum sample volume aspirated precisely at one time 2 µL
Supplied with UPS (backup power)/Requires floor drain available (not included)/no
Requires dedicated water system/Water consumption per hour no/0
Noise generated in decibels idle: 60; operational: 65
Dedicated pediatric sample cup/Dead volume no special sample cup required/35 µL
Primary tube sampling/Pierces caps on primary tubes yes/no
Sample bar-code reading capability/Autodiscrimination yes, on sample transport, shortly before sample is aspirated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes
Reagent bar-code reading capability yes
Bar code placement per CLSI standard Auto2A yes
Onboard test auto inventory (determines volume in container) yes
Measures number of tests remaining/Short sample detection/Clot detection yes/yes/yes
Hemolysis/Turbidity detection-quantitation yes/yes
Sample volume can be reduced system autodilutes
Increased to rerun out-of-linear-range high/low results no
Autocalibration or autocalibration alert yes
Calibrants stored onboard/Multipoint calibration supported no/yes
Typical calib. frequency for ISE/Metabolites/Therapeutic drugs/Drugs of abuse reagent lot change/reagent lot change/reagent lot change/reagent lot change
Automatic shutdown programmable/Startup programmable no/no
Stat time to completion of all analytes and throughput per hour for:
• Sodium, potassium, chloride, TC02 5.5 minutes, 100 specimens
• Sodium, potassium, chloride, TC02, glucose, urea, creatinine 5.75 minutes, 90 specimens
• Albumin, direct and total bilirubin, AST, ALT, ALP 7.5 minutes, 60 specimens
Typical time delay from ordering stat test to aspiration of sample about 10 seconds
How often QC required/Onboard SW capability to review QC once per 24 hours/yes
Onboard real-time QC/Support multiple QC lot numbers per analyte yes/yes
System can automatically transfer QC results to LIS yes
Data management capability/Instrument vendor supplies LIS interface onboard/no
Interfaces to what LISs up and running in active user sites all major LIS vendors
Bidirectional interface capability yes (broadcast download and host query)
Uses LOINC to transmit orders and results across interface no
How labs get LOINC codes for reagent kits technical service
Interface available (or will be) to automated specimen-handling system yes (enGen LAS)
Modem servicing available/System can diagnose own malfunctions/System can determine malfunctioning component yes/yes/yes
On-site time of service engineer 4–8 hours
Mean time between failures/Mean time to repair failures
Average time to complete maintenance by lab personnel
Onboard maintenance records/Maintenance training demo module yes, includes audit trail/yes
Training provided with instrument purchase 5 days on site, 5 days at company offices
Distinguishing features (provided by vendor) capability to add or remove reagents and consumables, and empty solid and liquid waste while operating; sample-centered processing integration approach eliminates need to move sample trays or aliquote samples between chemistry and immunoassay processing modules; integrates chemistry, immunoassay, and infectious-disease testing, and process them in parallel; integrated MicroTip technology expands menu availability, such as DATs, TDMs, specific proteins, %HbA1c and user-defined channels; MicroSensor technology detects interfering levels of hemolysis, icterus, and turbidity; eConnectivity assists with remote diagostics, software, and test parameter downloads and updates
Note: a dash in lieu of an answer means company did not answer question or question is not applicable