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510(k) K192063

PGDx elio tissue complete by Personal Genome Diagnostics — Product Code PZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2020
Date Received
August 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Next Generation Sequencing Based Tumor Profiling Test
Device Class
Class II
Regulation Number
866.6080
Review Panel
PA
Submission Type

A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.

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  • K202304 — NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (July 14, 2021)
  • K190661 — Omics Core (November 9, 2019)
  • DEN170058 — MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybrid (November 15, 2017)