21 CFR 866.6040 — Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Immunology (IM) · Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems · § 866.6040
Identification
A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NYI | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | 2 | 10 | |
| OVQ | Chronic Lymphocytic Leukemia Fish Probe Kit | 2 | 2 | 3rd Party |
| OWK | Early Growth Response 1 (Egr) Fish Probe Kit | 2 | 1 | 3rd Party |
| OWM | Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers | 2 | 1 | SaMD |
Special Controls
NYI — Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
eCFR
NYI — Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
Ecfr Llm
OVQ — Chronic Lymphocytic Leukemia Fish Probe Kit
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
eCFR
OWK — Early Growth Response 1 (Egr) Fish Probe Kit
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
eCFR
OWM — Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
eCFR
