| Device |
device for home collection and transport of vaginal specimens by lay users for use in an approved hpv molecular assay |
| Definition |
A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay with which the device has been validated. |
| Physical State |
A device consisting of components for vaginal specimens self-collection and transport. |
| Technical Method |
Lay user uses a device to self-collect and transport vaginal specimens for laboratory testing using an approved HPV molecular assay with which the device has been validated. |
| Target Area |
Vagina. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | SEP |
|---|
| Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.2920
|
|---|
| 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 |
