| Device Type ID | 6028 |
| Device Name | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Regulation Description | Cocaine And Cocaine Metabolite 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 | 862.3250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DIO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 6028 |
| Device | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Product Code | DIO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cocaine And Cocaine Metabolite Test System. |
| CFR Regulation Number | 862.3250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOPHOR DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GUANGZHOU WONDFO BIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HANMEDICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALGEN SCIENTIFIC, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMMUNALYSIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MP BIOMEDICALS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUEST DIAGNOSTICS INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THERMO FISHER SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Positive Result | 30 |
Incorrect Or Inadequate Test Results | 9 |
False Negative Result | 4 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 44 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Branan Medical Corporation | III | Aug-01-2016 |
| 2 | Branan Medical Corporation | II | Apr-24-2014 |
| 3 | OraSure Technologies, Inc. | III | Apr-18-2018 |
| 4 | Ortho-Clinical Diagnostics | II | Jan-23-2014 |