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 Immunology (IM) review panel, including product codes and regulations.
Section range: §§ 866.6010–866.6040
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | 866.6010 | 2 | 29 |
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | 866.6010 | 2 | 17 |
| LOQ | Device, General Purpose, Hematology | 866.6010 | 2 | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 866.6010 | 2 | 37 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 866.6010 | 2 | 26 |
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | 866.6010 | 2 | 9 |
| MOI | System, Test, Immunological, Antigen, Tumor | 866.6010 | 2 | 28 |
| MSW | System, Test, Thyroglobulin | 866.6010 | 2 | 13 |
| MUT | Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer) | 866.6010 | 2 | 0 |
| NCW | System, Test, Her-2/Neu, Monitoring | 866.6010 | 2 | 3 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 866.6010 | 2 | 11 |
| NTY | System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer | 866.6010 | 2 | 1 |
| NVA | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma | 866.6010 | 2 | 0 |
| OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | 866.6010 | 2 | 5 |
| OVK | Cytokeratin Fragments 21-1 Eia Kit | 866.6010 | 2 | 3 |
| OXP | Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment | 866.6010 | 2 | 1 |
| QTE | Thymidine Kinase Activity | 866.6010 | 2 | 1 |
| QXS | Chromogranin A | 866.6010 | 2 | 1 |
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | 866.6020 | 2 | 13 |
| NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 866.6030 | 2 | 2 |
| OAU | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma | 866.6030 | 2 | 1 |
| NYI | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | 866.6040 | 2 | 10 |
| OVQ | Chronic Lymphocytic Leukemia Fish Probe Kit | 866.6040 | 2 | 2 |
| OWK | Early Growth Response 1 (Egr) Fish Probe Kit | 866.6040 | 2 | 1 |
| OWM | Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers | 866.6040 | 2 | 1 |
