510(k) K191973
K191973 is an FDA 510(k) premarket notification submitted by Fujirebio Dianostics, Inc. for the device "Lumpipulse G CA19-9-N". The FDA issued a decision of Substantially Equivalent on October 22, 2019. The device falls under product code NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer), a Class II device regulated under 21 CFR 866.6010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2019
- Date Received
- July 24, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type
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.