(127 days)
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.
The Access BR Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of CA 15-3 antigen in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter Access BR Monitor, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance/Result |
|---|---|---|
| Imprecision (Analytical) | Within-run imprecision (CV) | Ranged from 1.4% CV to 2.2% CV for concentrations from ~15 to 662 U/mL. |
| Between-run imprecision (CV) | Ranged from 1.6% CV to 4.1% CV. | |
| Total imprecision (CV) | Ranged from 2.1% CV to 4.6% CV. | |
| Analytical Sensitivity | Lowest detectable level of CA 15-3 antigen |
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
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.(b)
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.