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| Device | xT CDx |
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| Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
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| Applicant | Tempus Labs, Inc.
600 W. Chicago Avenue, Suite 510
Chicago, IL 60654 |
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| PMA Number | P210011 |
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| Date Received | 03/23/2021 |
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| Decision Date | 04/28/2023 |
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| Product Code |
PQP |
| Advisory Committee |
Pathology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the xT CDx. The device is a qualitative Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for use in the detection of substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes, as well as microsatellite instability (MSI) status, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens, and DNA isolated from matched normal blood or saliva specimens, from previously diagnosed cancer patients with solid malignant neoplasms.The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling.Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.xT CDx is a single-site assay performed at Tempus Labs, Inc., Chicago, IL. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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