| Device Type ID | 6052 |
| Device Name | Enzyme Immunoassay, Methadone |
| Regulation Description | Methadone Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DJR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 6052 |
| Device | Enzyme Immunoassay, Methadone |
| Product Code | DJR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Methadone Test System. |
| CFR Regulation Number | 862.3620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HANMEDICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IMMUNALYSIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIN-ZHI INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Incorrect Or Inadequate Test Results | 1 |
Use Of Incorrect Control Settings | 1 |
False Positive Result | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alere San Diego Inc. DBA Immunalysis Corporation | III | Jun-08-2018 |
| 2 | Alere San Diego, Inc. | II | Mar-17-2014 |