| Device |
system for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home |
| Definition |
This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use. |
| Physical State |
In vitro diagnostic test system consisting of home collection kit and reagents and associated instrumentation for the detection of nucleic acid sequences from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home collected specimens. |
| Technical Method |
In vitro diagnostic test system that detects and identifies nucleic acid sequences from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in home collected specimens. |
| Target Area |
Home collected urogenital specimens from users suspected of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) infection. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | QYA |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3385
|
|---|
| 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 |
