PMA approvals

MI Cancer Seek

Caris Life Sciences · Next generation sequencing oncology panel, somatic or germline variant detection system · Medical Genetics

P240010 S007SupplementApproved
Open FDA's page for this record
PMA number
P240010
Supplement number
S007
Applicant
Caris Life Sciences
Street 1
4610 S. 44th Pl.
City
Phoenix
State
AZ
Zip
85040
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Trade name
MI Cancer Seek
Product code
PQP
Advisory committee
MG
Advisory committee description
Medical Genetics
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Expedited review flag
N
Date received
2025-11-26
Decision date
2026-10-16
Decision code
APPR
Ao statement

Approval for migration of the MI Cancer Seek (MCS) Bioinformatics Pipeline from an on-premises High-Performance Computing (HPC) cluster to Amazon Web Services (AWS) cloud infrastructure

Harmonized identifiers (openFDA)
Device name
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Medical specialty description
Unknown
Device class
3
Registration number
3007287152, 3017020141, 3010679023, 3011104381, 3012090384, 3020703032, 3011805506, 3003335080, 3013200421, 3031598391, 3030654068, 3003218906, 3010889807
FEI number
3016560486, 3007287152, 3010679023, 3011104381, 3012090384, 3008335090, 3011805506, 3003335080, 3013200421, 3031598391, 3030654068, 3003218906, 3010889807
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.