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This site is not affiliated with or endorsed by the FDA. Labeling does not contain MRI Safety InformationįDA Pre-market Approvals/Notifications & deNovoĪnalyzer, Chemistry (Photometric, Discrete), For Clinical Useĭevice Entry Metadata Public Version StatusĬRP Latex Calibrator Highly Sensitive (HS) Set Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory, automated Primary Device ID
#Beckman coulter au5800 series
Observed between method differences suggest ALP, GGT, LD, TBIL, and TP harmonization should be considered.AU GUDID 14987666543016 AU5800 Chemistry Analyzer Beckman Coulter, Inc. The AU5800 series represents the highest throughput and fastest chemistry analyzers in the AU family. Maximize throughput with an intelligent sample management system that optimizes the processing of racks based on the tests ordered Ensure quick turnaround time. The Beckman-Coulter AU 5800 demonstrates good linearity, low imprecision, and good correlation with previous methods. Linearity was excellent with R2 > 0.997 and deviations met accepted goals.
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For LD and TP several between method differences were outside boundaries describing expected bias. on an AU 5800 platform, which were used to calculate sigma metrics. Methods: This method was compared with existing. Beckman Coulter AU Chemistry Method Performance Three Years Later - Any Improvements. For GGT, between method TAE (23 to 51%) was predictable from expected bias and combined method imprecision. The performance of this assay was evaluated on the Beckman Coulter AU5800 Clinical Chemistry System. TAE between methods met allowable total error for 21 analytes.
#Beckman coulter au5800 professional
A (May 2013) Beckman Coulter Professional Development Clean the Mix Bar Wash Wells Ensure the system is in Standby Mode Open the front and rear main cover on each analyzer unit Place a in the Analyzer Maintenance check box Select Replace Mix Bar. Average bias versus Unicel DxC800 is high for ALP (17.3%), GGT (37%), LD (20%), TBIL (-23%), and TP (8%) and was confirmed in other laboratories. AU5800, Customer, Monthly Maintenance Job Aids of 9 Rev. Select the Group of Tests for processing 5. Total analytical error (TAE) was estimated for each method and between the tested and the comparative method, the Beckman-Coulter Unicel DxC800.ĬLSI EP15 total imprecision CV (TCV) 0.975, except for Cl (0.971), TP (0.964), and Na (0.948). AU5800 Daily Startup AU5800, Customer, Daily Startup Job Aid of 2 Version 2.0 (September 2018) Beckman Coulter Professional Development Does the New Index dialog display on the screen Set a New Index 1. Commutability of control material was tested. Repeat patient testing and IQC were also used for imprecision. Analytical performance of 24 Beckman-Coulter AU 5800 methods was verified against recognized quality goals and manufacturer's expected imprecision and bias.ĪU5800 method imprecision, bias, agreement with a comparative method, and linearity were studied using CLSI protocols, commercial control material, patient samples, and linearity test kit solutions. For Beckman Coulters worldwide office locations and phone numbers, please visit Contact Us at.