| Device |
device for home collection and transport of specimens by lay users for use in a cleared non-viral sti molecular assay |
| Definition |
A device for home collection and transport of specimens by lay users for use in a cleared non-viral STI molecular assay is a device intended for use by lay users in home settings or similar environments for the collection and transportation of specimens for testing using a cleared non-viral STI molecular assay with which the device has been validated. |
| Physical State |
A device consisting of components for self-collection and transport of specimens. |
| Technical Method |
Lay user uses a device to self-collect and transport specimens for laboratory testing using a cleared non-viral STI molecular assay with which the device has been validated. |
| Target Area |
Various anatomic sites appropriate for specimen collection by lay users. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | SIH |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
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 |
