# K190661: Omics Core

- Pathway: 510(k) (Traditional)
- Applicant: Nanthealth, Inc.
- Decided: Nov 9, 2019 after 240 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
Longest line of descent: 1 generation back to DEN170058 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170058: MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay, Memorial Sloan-Kettering Cancer Center (2017) Summary page 7.

## Indications for use
The Omics Core assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and tumor mutational burden (TMB) 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. Omics Core is a single-site assay performed at NantHealth, Inc.

Source page: https://510kreport.com/device/K190661
Methodology: https://510kreport.com/methodology