Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart G — Tumor Associated Antigen Immunological Test Systems](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems) → [21 CFR 866.6040](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6040) → OWM — Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

# OWM · Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

_Immunology · 21 CFR 866.6040 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OWM

## Overview

- **Product Code:** OWM
- **Device Name:** Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
- **Regulation:** [21 CFR 866.6040](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6040)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## 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](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OWM/K101185.md) | NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY | Iris Molecular Diagnostics | Sep 20, 2011 | SESE |

## Top Applicants

- Iris Molecular Diagnostics — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OWM](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OWM)

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