Device |
test, tricyclic antidepressants, over the counter |
Regulation Description |
Tricyclic antidepressant drugs test system. |
Definition |
Intended to measure any of the tricyclic antidepressant drugs in serum or urine. |
Physical State |
The device may be composed of a collection apparatus and/or detection assay. |
Technical Method |
Urine is collected and analyzed for the presence of antidepressant drugs. |
Target Area |
Urine |
Regulation Medical Specialty |
Toxicology |
Review Panel |
Toxicology |
Product Code | QAW |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.3910
|
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
|
Accredited Persons
|