(47 days)
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer and designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum. It is intended for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer.
The provided document is a 510(k) premarket notification letter from the FDA regarding the IMMULITE 2000 Carcinoembryonic Antigen (CEA) Kit. It confirms the device's substantial equivalence to previously marketed devices. However, this document does not contain the acceptance criteria or details of the study that proves the device meets those criteria.
The letter only states that the FDA has reviewed the 510(k) and found the device substantially equivalent for its intended use, which is for the quantitative measurement of CEA in serum as an aid in the management of cancer patients and in the assessment of prognosis.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text. This information would typically be found in the 510(k) submission itself, which is not included here.
§ 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.