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IMMULITE 2000 Thyroglobulin is a two-site chemiluminescent immunometric assay for use with the IMMULITE 2000 Analyzer and designed for the quantitative measurement of thyroglobulin in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in monitoring patients who have undergone thyroidectomy.

IMMULITE 2000 Thyroglobulin is a clinical device for use with the IMMULITE 2000 Automated Immunoassay Analyzer. IMMULITE 2000 Thyroglobulin is a chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase. The patient sample, a ligand-labeled anti-thyroglobulin monoclonal antibody and an alkaline phosphatase-labeled anti-thyroglobulin polyclonal antibody are simultaneously introduced into the Reaction Tube containing the bead and incubated for approximately 60 minutes at 37℃ with intermittent agitation. During this time, thyroglobulin in the sample forms an antibody sandwich complex which, in turn, binds to anti-ligand on the solid phase. Unbound conjugate is removed by a centrifugal wash; substrate is then added and the Reaction Tube is incubated for a further 5 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of thyroglobulin in the sample.

The provided document describes the IMMULITE 2000 Thyroglobulin device, an in vitro diagnostic assay, and its comparison to a predicate device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents a comparison study with a predicate device and reports sensitivity, specificity, and agreement. For the purpose of this response, I will interpret the performance metrics relative to the predicate device as the reported performance, implying that these values were considered acceptable for demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 150 samples.
• Data Provenance: The samples were from "patients with Hashimoto's disease, Graves disease, patients who had undergone thyroidectomy, as well as euthyroid individuals." The country of origin is not specified, but the manufacturing and importer details suggest a US and European context. The study appears to be retrospective as it involved collecting samples for comparison.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The "ground truth" for the test set was established by comparing the IMMULITE 2000 Thyroglobulin device's results against a commercially available predicate device (Kit A - ALPCO's ORGenTec), not against expert consensus on individual cases.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparison was an analytical method comparison between two in vitro diagnostic devices, not a clinical adjudication by experts. The results were tabulated based on the respective assays' suggested cutoffs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This study is a method comparison for an in vitro diagnostic assay, not an imaging or interpretive device that would typically involve human readers.

6. Standalone Performance Study

• Standalone Performance: Yes, the device's performance (sensitivity, specificity, agreement, and correlation) was evaluated independently by comparison to a predicate device. While it's a comparison, it establishes the standalone analytical performance of the new device against an accepted method.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" was established by the measurements obtained from a commercially available predicate device (ORGenTec Thyroglobulin ELISA, referred to as "Kit A"). It is not based on pathology, expert consensus, or clinical outcomes data directly; rather, it uses an established, legally marketed assay as the reference standard.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information about a "training set." This type of in vitro diagnostic assay typically involves analytical validation and calibration rather than machine learning training sets in the modern sense. The study described is a method comparison for performance validation.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as no separate "training set" is described or implied in the context of this device's validation. Calibration and analytical performance are typically established through internal methods and reference materials during development, but this document focuses on the method comparison study for regulatory submission.

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