Search Results
Found 1 results
510(k) Data Aggregation
K Number
K202304Device Name
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
Manufacturer
NYU Langone Medical Center
Date Cleared
2021-07-14
(334 days)
Product Code
PZM
Regulation Number
866.6080Why did this record match?
Applicant Name (Manufacturer) :
NYU Langone Medical Center
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 with solid malignant neoplasms to detect tumor gene alterations in a 607-gene panel. The test is intended to provide information on somatic 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.
Device Description
Not Found
Ask a Question
Page 1 of 1