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 |