FDA 510K for Cardiac Allograft Gene Expression Profiling Test System
A Cardiac Allograft Gene Expression Profiling Test System is a diagnostic tool used to analyze gene expression levels in heart transplant patients. It helps detect signs of organ rejection by measuring specific genes related to the immune response. This test provides a non-invasive way to monitor transplant health and guide treatment decisions.
Intended Use of Cardiac Allograft Gene Expression Profiling Test System
A Cardiac Allograft Gene Expression Profiling Test System is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern, classifier, index, score) to aid in the identification of a low probability of acute cellular rejection (ACR) in heart transplant recipients with stable allograft function.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Cardiac Allograft Gene Expression Profiling Test System
FDA 510K for Cardiac Allograft Gene Expression Profiling Test System Device Code and Regulation Number
| S.
No |
Product Code | Device Name | Regulation Description | Regulation Number | Device Class |
| 1. | OJQ | Cardiac Allograft Gene Expression Profiling Test System | Cardiac Allograft Gene Expression Profiling Test System | 862.1160 | 2 |
Cardiac Allograft Gene Expression Profiling Test System
Intended Use
It is an 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.
Device Description
The device is a Cardiac Allograft Gene Expression Profiling Test System that measures the expression levels of multiple genes in patient samples to generate a score used to aid in identifying a low probability of acute cellular rejection in stable heart transplant recipients.The test begins with blood collection in specialized tubes. The PBMCs are separated, lysed, and shipped frozen to the laboratory for analysis. Once received, the samples undergo RNA extraction, purification, and conversion to cDNA. The quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) method is then used to measure the expression levels of 20 genes—11 informative and 9 for quality control. A proprietary algorithm calculates the device Test Score, which ranges from 0 to 40, indicating the probability of acute cellular rejection (ACR).
Performance Testing (Analytical) for Cardiac Allograft Gene Expression Profiling Test System
- Precision/Reproducibility
- Analytical Specificity/Interference
- Assay Reportable Range
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
- Detection Limit
- Accuracy (Instrument)
- Method Comparison
Clinical Testing
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