OWM · Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
Immunology · 21 CFR 866.6040 · Class 2
Overview
| Product Code | OWM |
|---|---|
| Device Name | Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers |
| Regulation | 21 CFR 866.6040 |
| Device Class | Class 2 |
| Review Panel | Immunology |
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.
Special Controls
The device is classified as Class II under regulation 21 CFR 866.6040 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Gene expression profiling test system for breast cancer prognosis" is available at http://www.fda.gov/cdrh/oivd/guidance/1627.html.
*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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101185 | NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY | Iris Molecular Diagnostics | Sep 20, 2011 | SESE |
Top Applicants
- Iris Molecular Diagnostics — 1 clearance
