Definition: Intended For Use In The Collection, Preservation, And Transport Of Oral Fluid Specimens For Drugs Of Abuse Or Alcohol Testing.
| Device Type ID | 662 |
| Device Name | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Physical State | Specimen Collection Device, Which May Include An Absorbent Oral Fluid Collection Pad And/or A Specimen Storage Container For Collection, Preservation And Transport. |
| Technical Method | Collects Oral Fluid And Stabilizes It For Transport Or Storage. |
| Target Area | Clinical Samples (oral Fluid) |
| Regulation Description | Blood Specimen Collection Device. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1675 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 662 |
| Device | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Product Code | PJD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Specimen Collection Device. |
| CFR Regulation Number | 862.1675 [🔎] |
| Device Problems | |
|---|---|
Chemical Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |