Device |
oral fluid drugs of abuse and alcohol test specimen collection device |
Regulation Description |
Blood specimen collection device. |
Definition |
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing. |
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 Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | PJD |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.1675
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |