MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
Device Facts
| Record ID | K000566 |
|---|---|
| Device Name | MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product Code | LTJ · Immunology |
| Decision Date | Mar 9, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
