Not Cleared Direct

DEN230046 - PGDx elio plasma focus Dx (FDA 510(k) Clearance)

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230046 · Personal Genome Diagnostics, Inc. · Pathology device
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Aug 2024
Decision
398d
Days
Class 2
Risk

DEN230046 is an FDA 510(k) submission (not cleared) for the PGDx elio plasma focus Dx. Classified as High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids (product code SBY), Class II - Special Controls.

Submitted by Personal Genome Diagnostics, Inc. (Blatimore, US). The FDA issued a Not Cleared (DENG) decision on August 1, 2024 after a review of 398 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6085 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 398 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Personal Genome Diagnostics, Inc. devices

Submission Details

510(k) Number DEN230046 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 30, 2023
Decision Date August 01, 2024
Days to Decision 398 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 77d · This submission: 398d
Pathway characteristics

Device Classification

Product Code SBY High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6085
Definition A High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-free Nucleic Acids Is A Qualitative In Vitro Diagnostic Test Intended For Next Generation Sequencing Analysis Of Circulating Cell-free Nucleic Acids From Plasma Samples Collected From Peripheral Whole Blood To Detect Mutations In A Panel Of Targeted Genes To Aid In The Management Of Previously Diagnosed Cancer Patients By Qualified Health Care Professionals. The Results Of The Test Are Not Prescriptive Or Conclusive For Use Of Any Specific Therapeutic Product.
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.