| Device |
culture-based short-term incubation antimicrobial resistance assay |
| Regulation Description |
System for detection of microorganisms and antimicrobial resistance using reporter expression. |
| Definition |
A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection. |
| Physical State |
In vitro diagnostic device consisting of reagents and instrumentation for the detection and identification of microorganisms and determination of antimicrobial drug susceptibility or resistance directly in clinical specimens. |
| Technical Method |
In vitro diagnostic device that uses expression of transduced reporter genes for the detection and identification of microorganisms and determination of associated antimicrobial drug susceptibility or resistance directly in clinical specimens. |
| Target Area |
Clinical specimens from patients suspected of microbial colonization or infection. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | QIV |
|---|
| Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.1655
|
|---|
| 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 |
