Search Results

IMMULITE® Anti-TG Ab is a solid-phase, two-step chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Immunoassay Analyzer and designed for the quantitative measurement of antibodies against thyroglobulin (TC) in serum, EDTA, heparinized, and citrate plasma. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of thyroid diseases.

IMMULITE® Anti-TG Ab is a clinical device for use with IMMULITE® the Automated Immunoassay Analyzer. IMMULITE® Anti-TG Ab is a solid-phase, two-step chemiluminescent enzyme immunometric assay. The solid-phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with highly purified thyroglobulin.

Here's a breakdown of the acceptance criteria and the study that proves the IMMULITE Anti-TG Ab device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 137 patient samples
• Data Provenance: Not explicitly stated, but it is clear the samples are clinical patient samples. The document does not specify country of origin or if they were retrospectively or prospectively collected.

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

This information is not provided in the document. The study compares the new device against a predicate device, which implies the predicate device's results are considered a form of "ground truth" for the comparison, but it does not describe how the ground truth for that predicate was established or how experts were involved in this specific comparison.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on the analytical performance of one automated immunoassay device compared to another.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this was a standalone performance study. The IMMULITE Anti-TG Ab is an automated immunoassay device, meaning its performance in determining anti-TG Ab concentration is assessed intrinsically, without human interpretation for the result itself. The study compared its output to another automated immunoassay (the predicate device).

7. Type of Ground Truth Used

The "ground truth" for this study was the results obtained from the predicate device, the ORGenTec Anti-TG PIN Immuno Assay. The study aimed to demonstrate substantial equivalence by comparing the IMMULITE Anti-TG Ab's results against those of an already marketed and cleared device.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This is a laboratory immunoassay device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such devices typically involves calibration and quality control procedures, which are not described in terms of a data set size in this summary.

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

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.

Ask a specific question about this device