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U.S. Department of Health and Human Services

Product Classification

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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 CodePZM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Accredited Persons
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