| Device Type ID | 6003 |
| Device Name | Enzyme Immunoassay, Tracrolimus |
| Regulation Description | Tacrolimus Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1678 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MLM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6003 |
| Device | Enzyme Immunoassay, Tracrolimus |
| Product Code | MLM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tacrolimus Test System. |
| CFR Regulation Number | 862.1678 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 32 |
Low Test Results | 4 |
Mechanical Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 45 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Diasorin Inc. | II | Apr-20-2015 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |