(112 days)
AIA-PACK CA 125 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on TOSOH AIA System analyzers. AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Not Found
The provided text is an FDA 510(k) clearance letter for the AIA-PACK CA 125 Assay. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. However, the document does NOT contain a study or data proving the device meets specific acceptance criteria, nor does it detail any of the requested information regarding sample sizes, ground truth establishment, or expert involvement in a study.
Therefore, I cannot provide the requested table and study details from the provided text. The document is an administrative clearance, not a scientific study report.
§ 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.