Definition: The Cocaine And Cocaine Metabolite Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Cocaine And Cocaine Metabolites For Employment And Insurance Testing. FDA Has Exempted These Devices From The Premarket Notification Requirement By
| Device Type ID | 6263 |
| Device Name | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Immunoassay |
| Target Area | In Vitro Specimen |
| 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) Exempt |
| CFR Regulation Number | 862.3250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PVA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6263 |
| Device | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt |
| Product Code | PVA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cocaine And Cocaine Metabolite Test System. |
| CFR Regulation Number | 862.3250 [🔎] |
| Device Problems | |
|---|---|
Fail-Safe Design Failure | 1 |
Nonstandard Device | 1 |
Device Slipped | 1 |
| Total Device Problems | 3 |