Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | MI Cancer Seek |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Caris Life Sciences 4610 South 44th Place Phoenix, AZ 85040 |
PMA Number | P240010 |
Date Received | 04/01/2024 |
Decision Date | 11/05/2024 |
Product Code |
PQP |
Docket Number | 24M-5719 |
Notice Date | 12/20/2024 |
Advisory Committee |
Molecular Genetics |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval order for MI Cancer Seek. MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 below, in accordance with the approved therapeutic product labeling (see approval order for Table 1).Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S002 |
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