Cleared Traditional

ACTOnco, ACTOnco IVD

K210017 · Act Genomics · Pathology

Dec 2022

Decision

718d

Days

Class 2

Risk

About This 510(k) Submission

K210017 is an FDA 510(k) clearance for the ACTOnco, ACTOnco IVD, a Next Generation Sequencing Based Tumor Profiling Test (Class II — Special Controls, product code PZM), submitted by Act Genomics (Taipei, TW). The FDA issued a Cleared decision on December 23, 2022, 718 days after receiving the submission on January 4, 2021. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6080.

Submission Details

510(k) Number	K210017 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 2021
Decision Date	December 23, 2022
Days to Decision	718 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	PZM — Next Generation Sequencing Based Tumor Profiling Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6080
Definition	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.