| Device |
nucleic acid based assay, microsatellite instability |
| Definition |
The microsatellite instability (MSI) companion diagnostic is nucleic acid based (molecular) in vitro diagnostic device intended for the qualitative detection of a panel of molecular biomarkers for identification of MSI in human clinical tissue specimens. It reports MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H). The MSI companion diagnostic is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess MSI status which may be associated with a better clinical response to specific FDA approved therapeutic drugs. |
| Physical State |
The device contains the reagents to perform sample preparation and nucleic acids extraction for Microsatellite Instability (MSI) detection. The device may include hardware and software to allow for data collection and analysis. |
| Technical Method |
The test uses human clinical tissue specimens, from which nucleic acids are extracted and analyzed to determine the Microsatellite Instability (MSI) status. |
| Target Area |
Human clinical tissue specimens. |
| Review Panel |
Pathology |
|---|
| Product Code | SFL |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| 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 |
