Access Total Bhcg Reagents on the Access Immunoassay Analyzer; 33500, 33505

• • Terminated Z-1736-2011 FDA Unclassified (pre-2012) ·initiated 20 Oct 2010

  Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BhCG assay. These elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range. The role of preanalytical factors in laboratory testing has been described in a variety of published literature.

510(k) Number

K980173 ↗

FDA Product Code

JHI

Models / Variants

Access Total Bhcg Reagents On The Access Immunoassay Analyzer

33500, 33505

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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