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U.S. Department of Health and Human Services

Product Classification

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Device fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement
Definition A fluorescence in situ hybridization (fish) assay for pdgfrb rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the pdgfrb gene locus.It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate.
Physical State The device is a laboratory assay that consists of slide preparation materials, fluorescent FISH probes, buffers, nuclear counterstain, and a fluorescence-enabled microscope.
Technical Method The assay uses fluorescence in situ hybridization, manual method, with a dual-labeled break-apart DNA probe. When the PDGFRB genetic locus is intact, a single yellow signal is visualized and when it is rearranged separate red and green signals may be visualized and enumerated under fluorescent microscopy.
Target Area Human bone marrow aspirate or peripheral blood
Review Panel Molecular Genetics
Product CodePMI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type HDE - Humanitarian Device Exemption
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible