| Device Type ID | 3039 |
| Device Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| 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 | LTJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3039 |
| Device | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Product Code | LTJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NANOENTEK INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 43 |
High Test Results | 31 |
Mechanical Problem | 11 |
Incorrect Or Inadequate Test Results | 7 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Probe | 2 |
Mixer | 2 |
Incorrect Measurement | 1 |
Seal | 1 |
Device Subassembly | 1 |
Brush | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 108 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc | II | Sep-07-2016 |
| 2 | Tosoh Bioscience Inc | II | Jun-05-2018 |