Product Classification

• Device: next generation sequencing based tumor profiling test
• Regulation Description: Next generation sequencing based tumor profiling test.
• 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.
• Physical State: The test may also include specimen handling, nucleic acid purification methods, target enrichment, library preparation and sequencing reagents, instrument systems and software.
• Technical Method: High throughput, massive parallel targeted sequencing including molecular reagents for target enrichment, library preparation and sequencing using multiplexed polymerase chain reactions , sequencing instrumentation and bioinformatics software. May also include unique algorithms based on sequencing results for the purpose of deriving a clinical decision point for a qualitative result output.
• Target Area: Human tumor tissue specimens and matched normal tissue or matched peripheral whole blood.
• Regulation Medical Specialty: Pathology
• Review Panel: Pathology
• Product Code: PZM
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: 510(k)
• Regulation Number: 866.6080
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc