FDA product code SFL: Nucleic Acid Based Assay, Microsatellite Instability
SFL is the FDA product code for nucleic acid based assay, microsatellite instability. It is a Class III device, reviewed by the Pathology panel. Devices under SFL reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Nucleic Acid Based Assay, Microsatellite Instability |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SFL devices
openFDA lists no recalls for product code SFL.
Frequently asked questions
What is FDA product code SFL?
SFL is the FDA product code for nucleic acid based assay, microsatellite instability. It is a Class III device, reviewed by the Pathology panel.
What device class is SFL?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SFL
- Run a recall and safety report across every SFL manufacturer
- Watch product code SFL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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