(79 days)
The DPC IMMULITE 2000 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.
Not Found
This is a clearance letter from the FDA, not a study or regulatory submission containing performance criteria. Therefore, the requested information about acceptance criteria, study data, sample sizes, expert qualifications, and ground truth cannot be extracted from this document.
The document states that the "Immulite 2000 PSA Kit" is substantially equivalent to legally marketed predicate devices and 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. However, it does not provide details on how this substantial equivalence was determined, nor does it contain the study data or acceptance criteria used for that determination.
§ 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.