Manual

Appendix - 11
Page 94 14439.C 03/2013VerifyNow System User Manual | USA
• EachinstrumentistestedwithapreviouslyqualiedlotofVerifyNowtestdevices.
• TestingincludesmultiplereplicatesofpreviouslyqualiedlotsofWQCcontrolmaterials.
• EachlotofVerifyNowTestdevicesistestedagainstapreviouslyqualiedlotoftestdevices.Testing
includes multiple replicates of WQC and blood from several normal donors.
In summary, the VerifyNow System includes a comprehensive set of quality control features, which have
been designed and incorporated into the system. The VerifyNow quality control features control all
aspectsoftheanalyticalprocess,asdenedintheCLIARegulation:
• Test system – instrument and reagent system
• Operator
• Environmental factors
Running the VerifyNow System according to Accumetrics’ recommended procedures meets all the CLIA
quality control requirements.