Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- 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
- P240040Oncomine Dx Express TestAPPRPMA Approval
- P240010MI Cancer SeekAPPRPMA Approval
- P230011TruSight Oncology ComprehensiveAPPRPMA Approval
- P210011xT CDxAPPRPMA Approval
- P210040RESOLUTION ctDx FIRSTAPPRPMA Approval
- P200011ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)APPRPMA Approval
- P200016FoundationOne Liquid CDxAPPRPMA Approval
- P200006FoundationOne Liquid CDx (F1 Liquid CDx)APPRPMA Approval
- P190032FoundationOne Liquid CDx (F1 Liquid CDx)APPRPMA Approval
- P200010Guardant360 CDxAPPRPMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P160045Oncomine Dx Target Test (ODxT Test)3PMA Approval
- P160045Oncomine™ Dx Target Test3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P200011ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P170019FoundationOne CDx, FoundationOne Liquid CDx3PMA Approval
- P190032FoundationOne Liquid CDx (F1 Liquid CDx)3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P200010Guardant360 CDx3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P200010Guardant360 CDx3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P200016FoundationOne Liquid CDx3PMA Approval
- P200006FoundationOne Liquid CDx (F1 Liquid CDx)3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P190032FoundationOne Liquid CDx (F1 Liquid CDx)3PMA Approval
- P200010Guardant360 CDx3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P190014myChoice CDx3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P190014myChoice CDx3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P190014myChoice CDx3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P170019FoundationOne CDx Assay3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038Praxis (MiSeqDx) Extended RAS Panel3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P170019FoundationOne CDx (F1CDx)3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target3PMA Approval
- P160038MiSeqDx Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038MiSeqDx Praxis Extended RAS Panel3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160018FoundationFocus CDx BRCA HRD3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P170019FoundationOne CDx3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160038Praxis Extended RAS Panel3PMA Approval
- P160045Oncomine Dx Target Test3PMA Approval
- P160018FoundationFocus CDxBRCA3PMA Approval
- 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
- SFSRevumenib Eligibility Detection System2Product Code
- SFHPathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis2Product Code
- SFLIdylla Cdx Msi Test3Product Code
- SGDKit D816v Mutation Detection SystemFProduct 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
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FoundationOne CDx (F1CDx)
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Foundation Medicine, Inc.
- Trade Name
- FoundationOne CDx
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision Date
- 11/30/2017
- Days to Decision
- 181 days
- Decision Code
- APPR
- FDA Decision
- Approval