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- MiscellaneousMiscellaneous
- PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection2Product Code
- PSUJak2 Gene Mutation Detection Test2Product Code
- QAZCancer Predisposition Risk Assessment System2Product Code
- QDIFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies2Product Code
- MAODna-Probe, Human ChromosomeUProduct Code
- MKQProcessor, Cervical Cytology Slide, Automated3Product Code
- MNMReader, Cervical Cytology Slide, Automated3Product Code
- MTIKit, Cell Screening, FetalNProduct Code
- MVCSystem, Test, Her-2/Neu, Ihc3Product Code
- MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum3Product Code
- NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence3Product Code
- NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion3Product Code
- OQSLaboratory Developed TestNProduct Code
- OTUResearch Use Only/PathologyNProduct Code
- OWEFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement3Product Code
- PANBraf Mutation KitNProduct Code
- PDDInvestigational Use Only - PathologyNProduct Code
- PFUTissue Processing KitNProduct Code
- PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection3Product Code
- PJGCancer-Related Germline Gene Mutation Detection System3Product Code
- PKWImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase3Product Code
- PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 13Product Code
- PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System3Product Code
- QFISynthetic Next-Generation Sequencing Quality Control And Filler MaterialNProduct Code
- QFKTumor Gene Profiling TestNProduct Code
- QQTImmunohistochemistry Assay, Antibody, Ki-673Product Code
- QSACirculating Tumor Cell (Ctc) Enrichment Device2Product Code
- QVUHigh Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.2Product Code
- QYVDigital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm2Product Code
- SBBSystem, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection3Product Code
- SBYHigh Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
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High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
- Page Type
- Product Code
- Definition
- A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.
- Physical State
- The test may include specimen handling, nucleic acid purification methods, library preparation, target enrichment, and sequencing reagents, instrument systems and software. Should not include devices intended to aid in the diagnosis, prognosis, screening of cancer, or make or recommend treatment decisions.
- Technical Method
- The test system uses high throughput sequencing technology, including molecular reagents for library preparation, target enrichment, and sequencing, sequencing instrumentation and bioinformatics software, to detect variants in cell free nucleic acids isolated from peripheral whole blood in specified genes associated with malignant neoplasms.
- Target Area
- Human peripheral whole blood specimens
- Regulation Medical Specialty
- Pathology
- Review Panel
- Pathology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.6085
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code SBY is linked to regulation 21CFR866.6085, which does not seem to exist yet. It may be pending at the moment.