System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Medical specialty
Immunology
Device class
2
Regulation number
866.6010
Review panel
IM
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Definition
An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods.