System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Medical specialty
Immunology
Device class
2
Regulation number
866.6020
Review panel
PA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.