Next Generation Sequencing Based Tumor Profiling Test

PZM · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 866.6080

Classification

FDA Product Code: PZM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6080
Review panel: PA
Medical specialty: Pathology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown