Cleared Traditional

K202304 - NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (FDA 510(k) Clearance)

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

K202304 · Nyu Langone Medical Center · Pathology device
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Jul 2021
Decision
334d
Days
Class 2
Risk

K202304 is an FDA 510(k) clearance for the NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets). Classified as Next Generation Sequencing Based Tumor Profiling Test (product code PZM), Class II - Special Controls.

Submitted by Nyu Langone Medical Center (New York, US). The FDA issued a Cleared decision on July 14, 2021 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K202304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2020
Decision Date July 14, 2021
Days to Decision 334 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 77d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

New York State Department of Health
Derek Symula

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.