(282 days)
The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus CEA assay is indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients. These CEA values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is made. For in vitro diagnostic use only.
The Olympus CEA Calibrator is for calibrating the quantitative Olympus CEA assay on the Olympus AU3000i Immunoassay System.
The Olympus CEA Control is used for quality control of the Olympus CEA assay on the Olympus AU3000i Immunoassay System.
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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically regarding device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is primarily an FDA 510(k) clearance letter and an "Indications for Use" statement for the Olympus Carcinoembryonic antigen (CEA) Test System. It confirms the device's substantial equivalence to a predicate device and outlines its intended use but does not delve into the specifics of performance studies or acceptance criteria.
§ 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.