(153 days)
The Nichols Institute Diagnostics Chemiluminescence Thyroglobulin is a two-site immunometric assay for the quantitative measurement of thyroglobulin in human serum. The assay is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had prior thyroidectorny (using surgery with or without radioiodine). This assay is also indicated for monitoring thyroglobulin levels in combination with radioiodine whole body scans after either rhTSH administration or thyroid hormone withdrawal for detecting presence of thyroid tissue in patients with well-differentiated thyroid cancer. The assay should only be used on patients who lack thyroglobulin autoantibodies.
The Chemiluminescence Thyroglobulin kit has sufficient reagents for 100 tests. The throglobulin assay is a chemiluminescence sandwich immunoassay assay utilizing a biotinylated goat antiassay 1s a cheinnummicscented sunding monoclonal antibody labeled with acriding for detection. thyrogloutin for captare and a modio monomal and seprosilicate glass tube followed by the A U.200-IIL Serum Sample 1s added to a 12×10 uline and 0.050 mL of acridinium labeled antithyroglobulin reagents. Samples are also run at a 1/10 dilution (hook detection tube) to check for t thyroglountif teagents. Butiples are also in the assay. An avidin-coated bead is then added to the polentially mixture. The assay incubates at room temperature for 16-24 hours on top of a horizontal rotator set & 180 ± 10 rpm. Thyroglobulin in the serum sample binds to the biotinylated antibody and acridinium labeled antibody to form a sandwich-complex. Because of the high affinity between biotin and avidin, the captured sandwich complex binds to the avidin-coated bead. Free oetween brom and avidin, the capitaled antibody are separated from the complex bound to the bead by aspiration of the reaction mixture and subsequent washing. The tubes containing the washed beads are placed into a luminometer, which automatically injects Trigger 1 and 2, initiating the chemiluminescence reaction. The light is quantified by the luminometer and minating the onomianinessonts (RLU). The amount of acridinium labeled antibody bound is directly proportional to the concention of thyroglobulin in the sample. A log-log standard curve uncectly proportional to the concentration of the ordinate versus the respective concentration of each IS gelleration of proting the mount NFO shecissa. The concentration of thyroglobulin is determined directly from the standard curve.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core of the acceptance criteria seems to be framed around demonstrating substantial equivalence to a predicate device and showing clinical utility for its intended use. While explicit numerical acceptance criteria for sensitivity, specificity, etc., weren't
fully specified as pre-defined targets in the document, the clinical study's results (especially in Table 3) serve as the evidence for meeting acceptable performance for market clearance.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied / Contextual) | Reported Device Performance (Nichols Tg ICMA) |
|---|---|---|
| Method Comparison (Against Predicate) | ||
| Agreement ( |
§ 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.