System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
NIG · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6010
Classification
FDA Product Code
NIG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6010
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.