(118 days)
The DPC IMMULITE 2000 3rd Gen. PSA kit is intended for the quantitative measurement of prostate specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients.
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This document is an FDA 510(k) clearance letter for a medical device called "IMMULITE 2000 3rd Gen. PSA," which is a kit for the quantitative measurement of prostate specific antigen (PSA). This type of document does not contain the acceptance criteria, study details, or performance data requested in your prompt.
FDA 510(k) clearance letters primarily state that the device has been found substantially equivalent to a legally marketed predicate device. They do not typically include detailed reports of clinical studies, performance metrics, or ground truth establishment. These details would be found in the manufacturer's 510(k) submission, which is not provided here.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth methods based solely on the provided text.
§ 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.