| Device Type ID | 3040 |
| Device Name | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| 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 | LTK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3040 |
| Device | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Product Code | LTK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FUJIREBIO DIAGNOSTICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE PROFESSIONAL DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 12 |
Adverse Event Without Identified Device Or Use Problem | 12 |
High Test Results | 11 |
Incorrect Or Inadequate Test Results | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
High Readings | 1 |
Non Reproducible Results | 1 |
False Positive Result | 1 |
| Total Device Problems | 43 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc | II | Apr-24-2018 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |