(81 days)
is intended for the quantitative determination of thyroglobulin (Tg) in human serum as an aid in the detection of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioiodine), and who lack serum thyroglobulin antibodies.
Not Found
I am sorry, but the provided text from the FDA document does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is primarily a notification letter from the FDA regarding the substantial equivalence of the "Kronus Optiquant Thyroglobulin Kit" to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory classifications, general controls, and points of contact for additional information.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based 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.