| Device |
test for detection of microorganism(s) causing sexually transmitted infections performed by lay users |
| Definition |
This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use. |
| Physical State |
In vitro diagnostic device consisting of reagents and associated instrumentation for the detection of nucleic acid sequences from sexually transmitted non-viral microorganism(s). |
| Technical Method |
In vitro diagnostic self-testing device that detects and identifies nucleic acid sequences from sexually transmitted non-viral microorganism(s). |
| Target Area |
Clinical specimens from patients suspected of from sexually transmitted non-viral microorganism(s). |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | SEA |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3386
|
|---|
| 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 |
