NCW · System, Test, Her-2/Neu, Monitoring
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | NCW |
|---|---|
| Device Name | System, Test, Her-2/Neu, Monitoring |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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.
Special Controls
*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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Bayer Corp. | Jan 30, 2003 | SESE |
| K994112 | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) | Oncogene Science, Inc. | Sep 29, 2000 | SESE |
| K992228 | BAYER IMMUNO 1 HER-2/NEU ASSAY | Bayer Corp. | Sep 29, 2000 | SESE |
Top Applicants
- Bayer Corp. — 2 clearances
- Oncogene Science, Inc. — 1 clearance
