Cellsearch Circulating Tumor Cell Kit Model 7900001

• • Ongoing Z-1345-2022 FDA Class II ·initiated 20 May 2022

  High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

• • Terminated Z-1530-2018 FDA Class II ·initiated 4 Apr 2018

  Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.

• • Terminated Z-2406-2015 FDA Class II ·initiated 15 May 2015

  Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.

510(k) Number

K103502 ↗

FDA Product Code

NQI

Device Class

Class II

Regulation

21 CFR Part 866.6020

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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