21 CFR 866.6010 — System, Test, Carcinoembryonic Antigen
Immunology (IM) · Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems · § 866.6010
Identification
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification Rationale
Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | 2 | 29 | 3rd Party |
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | 2 | 17 | 3rd Party |
| LOQ | Device, General Purpose, Hematology | 2 | 1 | 3rd Party |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 2 | 37 | 3rd Party |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | 26 | 3rd Party |
| MMW | System, Test, Tumor Marker, Monitoring, Bladder | 2 | 9 | 3rd Party |
| MOI | System, Test, Immunological, Antigen, Tumor | 2 | 28 | 3rd Party |
| MSW | System, Test, Thyroglobulin | 2 | 13 | 3rd Party |
| MUT | Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer) | 2 | 0 | 3rd Party |
| NCW | System, Test, Her-2/Neu, Monitoring | 2 | 3 | 3rd Party |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | 11 | 3rd Party |
| NTY | System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer | 2 | 1 | 3rd Party |
| NVA | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma | 2 | 0 | 3rd Party |
| OIU | Test, Epithelial Ovarian Tumor Associated Antigen (He4) | 2 | 5 | 3rd Party |
| OVK | Cytokeratin Fragments 21-1 Eia Kit | 2 | 3 | 3rd Party |
| OXP | Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment | 2 | 1 | 3rd Party |
| QTE | Thymidine Kinase Activity | 2 | 1 | SaMD |
| QXS | Chromogranin A | 2 | 1 |
Special Controls
DHX — System, Test, Carcinoembryonic Antigen
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
LOJ — Kit, Test,Alpha-Fetoprotein For Testicular Cancer
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
LOQ — Device, General Purpose, Hematology
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
LOQ — Device, General Purpose, Hematology
Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
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LTJ — Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
LTK — Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
MMW — System, Test, Tumor Marker, Monitoring, Bladder
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
MOI — System, Test, Immunological, Antigen, Tumor
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
MSW — System, Test, Thyroglobulin
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
MUT — Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
NCW — System, Test, Her-2/Neu, Monitoring
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
NIG — System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
NTY — System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
NVA — Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
OIU — Test, Epithelial Ovarian Tumor Associated Antigen (He4)
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
OVK — Cytokeratin Fragments 21-1 Eia Kit
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
OXP — Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
QTE — Thymidine Kinase Activity
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
QXS — Chromogranin A
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
eCFR
