Immulite Om-Ma, Models Lkopz, LKOP1, LKOP5

• • Terminated Z-1682-2018 FDA Class II ·initiated 2 Jan 2018

  Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

510(k) Number

K981297 ↗

FDA Product Code

LTK

Models / Variants

Lkopz

LKOP1

LKOP5

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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