SFL

Nucleic Acid Based Assay, Microsatellite Instability

Product code

SFL

Device name

Nucleic Acid Based Assay, Microsatellite Instability

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).