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 Thei
| Device Type ID | 3062 |
| Device Name | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NIG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3062 |
| Device | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Product Code | NIG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 148 |
Adverse Event Without Identified Device Or Use Problem | 45 |
Incorrect Or Inadequate Test Results | 37 |
Low Test Results | 26 |
Non Reproducible Results | 3 |
High Readings | 2 |
No Apparent Adverse Event | 1 |
False Positive Result | 1 |
Device Component Or Accessory | 1 |
| Total Device Problems | 264 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Jun-28-2017 |
| 2 | ORTHO-CLINICAL DIAGNOSTICS | II | Aug-11-2014 |
| 3 | Siemens Healthcare Diagnostics, Inc | II | Nov-17-2016 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |