Ca 125 Assay for the Advia Centaur System

• • Terminated Z-1486-2018 FDA Class II ·initiated 21 Feb 2018

  Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.

• • Terminated Z-1477-2011 FDA Unclassified (pre-2012) ·initiated 14 Dec 2010

  Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal

510(k) Number

K020828 ↗

FDA Product Code

LTK

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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