NIG
11 FDA 510(k) clearances · Product code
87 daysmedian time to decision
92 days90th percentile
11clearances measured
FDA profile
- Official device name
- System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
- Adverse events (MAUDE)
- 2021: 69 · 2022: 83 · 2023: 129 · 2024: 121 · 2025: 100 · 2026: 76
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
| Lumipulse G CA19-9-N (K200997) | Fujirebio Diagnostics,Inc. | 2020-05-14 |
| Lumpipulse G CA19-9-N (K191973) | Fujirebio Dianostics, Inc. | 2019-10-22 |
| DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 (K100375) | Siemens Healthcare Diagnostics, Inc. | 2011-04-06 |
| VITROS CA 19-9 (K052889) | Fujirebio Diagnostics,Inc. | 2005-12-20 |
| ARCHITECT CA 19-9XR ASSAY (K052000) | Fujirebio Diagnostics,Inc. | 2005-10-25 |
| GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 (K033038) | Beckman Coulter, Inc. | 2003-12-29 |
| BAYER ADVIA CENTAUR CA 19-9 ASSAY (K031393) | Bayer Healthcare, LLC | 2003-06-24 |
| AIA-PACK CA 19-9 (K023239) | Tosoh Corp. | 2002-12-23 |
| ST AIA-PACK CA 19-9 (K023240) | Tosoh Corp. | 2002-12-23 |
| FUJIREBIO DIAGNOSTICS CA 19-9 RIA (K020566) | Fujirebio Diagnostics,Inc. | 2002-05-09 |
Track NIG automatically
Every clearance here is in the API, with alerts when new ones post.