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U.S. Department of Health and Human Services

Product Classification

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Device cardiac allograft gene expression profiling test system
Regulation Description Cardiac allograft gene expression profiling test system.
Definition In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment.
Physical State laboratory based test
Technical Method quantitative real-time polymerase chain reaction technology (qRT-PCR)
Target Area cardiac allograft
Regulation Medical Specialty Cardiovascular
Review Panel Clinical Chemistry
Product CodeOJQ
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1163
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible