| Device |
nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections |
| Definition |
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. |
| Physical State |
In vitro diagnostic device consisting of reagents and associated instrumentation for the detection of nucleic acid sequences from Mycoplasma genitalium in clinical specimens. |
| Technical Method |
In vitro diagnostic device that detects and identifies nucleic acid sequences from Mycoplasma genitalium in clinical specimens. |
| Target Area |
Clinical specimens from patients suspected of Mycoplasma genitalium infection. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | QEP |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3393
|
|---|
| 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 |
