| Device Type ID | 6213 |
| Device Name | Radioimmunoassay, Vancomycin |
| Regulation Description | Vancomycin 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 | 862.3950 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LEH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 6213 |
| Device | Radioimmunoassay, Vancomycin |
| Product Code | LEH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vancomycin Test System. |
| CFR Regulation Number | 862.3950 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS OPERATIONS (RDO) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 18 |
High Test Results | 15 |
Mechanical Problem | 14 |
Low Test Results | 12 |
Incorrect Or Inadequate Test Results | 3 |
Insufficient Information | 3 |
Device Ingredient Or Reagent Problem | 3 |
Probe | 2 |
Cross Reactivity | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Device Subassembly | 1 |
Unexpected Therapeutic Results | 1 |
Device Component Or Accessory | 1 |
Device Ingredient Or Reagent | 1 |
Non Reproducible Results | 1 |
| Total Device Problems | 78 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho-Clinical Diagnostics | II | Apr-27-2017 |
| 2 | Roche Diagnostics Operations, Inc. | II | Aug-01-2016 |