System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
The Carbohydrate Antigen CA19-9 Test System is an in vitro diagnostic device providing quantitative measurement of the CA 19-9 tumor-associated antigen in human serum or plasma, intended as an aid in managing patients with confirmed pancreatic cancer and for serial monitoring of their response to therapy and disease progression. The test is intended only for patients with elevated CA 19-9 values at diagnosis and must be used in conjunction with other clinical methods. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIG and regulation 21 CFR 866.6010 in the Immunology specialty. The device is eligible for third-party review and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NIG
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Aug 09, 2023 | Substantially Equivalent | Ortho Clinical Diagnostics |
| K200997 | Lumipulse G CA19-9-N | May 14, 2020 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K191973 | Lumpipulse G CA19-9-N | Oct 22, 2019 | Substantially Equivalent | Fujirebio Dianostics, Inc. |
| K100375 | DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 | Apr 06, 2011 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K052889 | VITROS CA 19-9 | Dec 20, 2005 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K052000 | ARCHITECT CA 19-9XR ASSAY | Oct 25, 2005 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 | Dec 29, 2003 | Substantially Equivalent | Beckman Coulter, Inc. |
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY | Jun 24, 2003 | Substantially Equivalent | Bayer Healthcare, LLC |
| K023240 | ST AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent | Tosoh Corp. |
| K023239 | AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent | Tosoh Corp. |
| K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA | May 09, 2002 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.