| Device Type ID | 3125 |
| Device Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MTF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3125 |
| Device | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Product Code | MTF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Low Test Results | 31 |
Adverse Event Without Identified Device Or Use Problem | 24 |
High Test Results | 21 |
Device Ingredient Or Reagent Problem | 15 |
Incorrect Or Inadequate Test Results | 7 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
No Apparent Adverse Event | 2 |
| Total Device Problems | 105 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Aug-06-2014 |
| 2 | Siemens Healthcare Diagnostics, Inc | II | Feb-04-2016 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | Jan-31-2017 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | Dec-22-2016 |