Nucleic Acid Based Assay, Microsatellite Instability
SFL · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SFL
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
PA
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.