NIG · System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | NIG |
|---|---|
| Device Name | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification Rationale
Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Special Controls
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho Clinical Diagnostics | Aug 9, 2023 | SESE |
| K200997 | Lumipulse G CA19-9-N | Fujirebio Diagnostics,Inc. | May 14, 2020 | SESE |
| K191973 | Lumpipulse G CA19-9-N | Fujirebio Dianostics, Inc. | Oct 22, 2019 | SESE |
| K100375 | DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 | Siemens Healthcare Diagnostics, Inc. | Apr 6, 2011 | SESE |
| K052889 | VITROS CA 19-9 | Fujirebio Diagnostics,Inc. | Dec 20, 2005 | SESE |
| K052000 | ARCHITECT CA 19-9XR ASSAY | Fujirebio Diagnostics,Inc. | Oct 25, 2005 | SESE |
| K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 | Beckman Coulter, Inc. | Dec 29, 2003 | SESE |
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY | Bayer Healthcare, LLC | Jun 24, 2003 | SESE |
| K023240 | ST AIA-PACK CA 19-9 | Tosoh Corp. | Dec 23, 2002 | SESE |
| K023239 | AIA-PACK CA 19-9 | Tosoh Corp. | Dec 23, 2002 | SESE |
| K020566 | FUJIREBIO DIAGNOSTICS CA 19-9 RIA | Fujirebio Diagnostics,Inc. | May 9, 2002 | SESE |
Top Applicants
- Fujirebio Diagnostics,Inc. — 4 clearances
- Tosoh Corp. — 2 clearances
- Bayer Healthcare, LLC — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Fujirebio Dianostics, Inc. — 1 clearance
