| Device Type ID | 3047 |
| Device Name | System, Test, Immunological, Antigen, Tumor |
| 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 | MOI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3047 |
| Device | System, Test, Immunological, Antigen, Tumor |
| Product Code | MOI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
High Test Results | 6 |
Mechanical Problem | 6 |
Incorrect Or Inadequate Test Results | 2 |
Low Test Results | 2 |
Failure To Calibrate | 2 |
Device Ingredient Or Reagent Problem | 1 |
Computer Operating System Problem | 1 |
Calibration Problem | 1 |
| Total Device Problems | 32 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-12-2017 |
| 2 | Siemens Healthcare Diagnostics, Inc | II | Apr-06-2017 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |