Gene Expression Profiling Test System for Breast Cancer Prognosis

Published On -

I3CGlobal IVDR, FDA 510k

FDA 510K for Gene Expression Profiling Test System for Breast Cancer Prognosis

A Gene Expression Profiling Test System designed for breast cancer prognosis is an apparatus that assesses the RNA expression levels of various genes. This data is then integrated to produce a signature, which may take the form of a pattern, classifier, or index, to assist in the prognosis of breast cancer that has already been diagnosed.

Intended Use of Gene Expression Profiling Test System for Breast Cancer Prognosis

A Gene Expression Profiling Test System for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.

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FDA 510K for Gene Expression Profiling Test System for Breast Cancer Prognosis Device Code and Regulation Number

S.

NO

 Product Code Device Regulation Description Regulation Number Device Class
1

NYI

 Classifier, Prognostic, Recurrence Risk Assessment, RNA Gene Expression, Breast Cancer Gene expression profiling test system for breast cancer prognosis.

866.604

2

Classifier, Prognostic, Recurrence Risk Assessment, RNA Gene Expression, Breast Cancer

Intended Use:

The gene expression profiling test system is an in vitro diagnostic device intended to analyze RNA gene expression patterns from breast cancer tumor tissue to provide prognostic information regarding the risk of cancer recurrence. The test is intended to be used as an aid in assessing recurrence risk in patients with breast cancer and to support clinical decision-making in conjunction with other clinical and pathological information..

Device Description:

The device is a gene expression profiling test system that consists of reagents for RNA extraction and analysis, assay components for measuring expression levels of a defined set of genes, and associated software for data analysis and result interpretation. The system operates by isolating RNA from tumor tissue specimens, measuring gene expression using molecular amplification and detection techniques, and applying an algorithm to generate a recurrence risk score. The mode of action is based on nucleic acid detection and computational analysis of gene expression patterns to produce a clinically relevant prognostic result.

Performance Testing (Analytical) for Gene Expression Profiling Test System for Breast Cancer Prognosis

Precision/Reproducibility

  • Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
  • Linearity/assay reportable range
  • Traceability (controls, calibrators, or method)
  • Analytical specificity

Clinical Testing:

No Guidance available for 510k submission

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