# K202304: NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

- Pathway: 510(k) (Traditional)
- Applicant: Nyu Langone Medical Center
- Decided: Jul 14, 2021 after 334 days
- Product code: PZM (Next Generation Sequencing Based Tumor Profiling Test)
- Device class: 2
- Regulation: 21 CFR 866.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The NYU Langone Genome PACT assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded (FFPE) tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a 607-gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. NYU Langone Genome PACT is a single-site assay performed at NYU Langone Health.

Source page: https://510kreport.com/device/K202304
Methodology: https://510kreport.com/methodology