Cleared Traditional

PGDx elio tissue complete (K192063) - FDA 510(k) Clearance

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192063 · Personal Genome Diagnostics · Pathology device
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Apr 2020
Decision
267d
Days
Class 2
Risk

K192063 is an FDA 510(k) clearance for the PGDx elio tissue complete. Classified as Next Generation Sequencing Based Tumor Profiling Test (product code PZM), Class II - Special Controls.

Submitted by Personal Genome Diagnostics (Baltimore, US). The FDA issued a Cleared decision on April 24, 2020 after a review of 267 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6080 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Personal Genome Diagnostics devices

Submission Details

510(k) Number K192063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2019
Decision Date April 24, 2020
Days to Decision 267 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 77d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZM Next Generation Sequencing Based Tumor Profiling Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - PZM Next Generation Sequencing Based Tumor Profiling Test

All 7
Devices cleared under the same product code (PZM) and FDA review panel - the closest regulatory comparables to K192063.
CellDx-Tissue
K260235 · Datar Cancer Genetics Private Limited · May 2026
xR IVD
K241868 · Tempus AI, Inc. · Sep 2025
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
K250003 · Geneseeq Technology, Inc. · Aug 2025
ACTOnco, ACTOnco IVD
K210017 · Act Genomics · Dec 2022
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
K202304 · Nyu Langone Medical Center · Jul 2021
Omics Core
K190661 · Nanthealth, Inc. · Nov 2019