Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems
FDA submissions for Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems in the Pathology (PA) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 866.6080–866.6100
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PZM | Next Generation Sequencing Based Tumor Profiling Test | 866.6080 | 2 | 7 |
| SBY | High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | 866.6085 | 2 | 1 |
| QVU | High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System. | 866.6095 | 2 | 1 |
| QDC | Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies | 866.6100 | 2 | 2 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K241868 | xR IVD | Tempus AI, Inc. | Sep 19, 2025 |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | Aug 29, 2025 |
| DEN230046 | PGDx elio plasma focus Dx | Personal Genome Diagnostics, Inc. | Aug 1, 2024 |
| DEN210011 | Invitae Common Hereditary Cancers Panel | Invitae Corporation | Sep 29, 2023 |
| K210017 | ACTOnco, ACTOnco IVD | Act Genomics | Dec 23, 2022 |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) | Nyu Langone Medical Center | Jul 14, 2021 |
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | Aug 5, 2020 |
| K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | Apr 24, 2020 |
| K190661 | Omics Core | Nanthealth, Inc. | Nov 9, 2019 |
| DEN170080 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | Sep 28, 2018 |
| DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay | Memorial Sloan-Kettering Cancer Center | Nov 15, 2017 |
