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The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate enzymelmmunoassay. The results obtained are used in the diagnosis and treatment of thyroid diseases such as hyperthyoidism.

Monobind Inc. , registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (EIA) kit for the determination of total trilodothyronine (T3) in human serum or plasma. The proprietary name is Total Trilodothyronine (T3) Microplate EIA and the usual name Is T3 EIA. This device classification name is - enzyme immunoassay, non-radiolabeled, total trilodothyronine - product code CPD (per 21 CRF section 862.1710). The Monobind microplate ElA utilizes anti-trilodothyronine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, callbrators or controls are then added followed by the enzyme-T3 conjugate. A competition reaction results between the native trilodothyronine in the sample and the added enzyme-T3 conjugate for a limited number of antibody combining sites. After the completion of the Incubation period, the enzyme-T3 conjugate is separated from unreacted material by decantation. The activity of the enzyme on the well is quantitated by reaction with suitable substrate to produce color.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monobind Total Triiodothyronine (T3) Microplate EIA:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for correlation coefficient, recovery, or linearity. However, the reported results are presented to demonstrate substantial equivalence and satisfactory performance. We can infer performance metrics from the reported data.

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

• Sample Size: 120 specimens.
• Data Provenance: The specimens were from "hypothyroid, euthyroid and hyperthyroid populations." The country of origin is not specified, but the company is based in Costa Mesa, CA, USA. The study appears to be retrospective, using existing specimens for comparison between the new and predicate devices.

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

This information is not provided in the submission. The ground truth for method agreement was established by running the samples on a predicate device (Monobind total trilodothyronine (T3) coated tube radioimmunoassay (RIA)), rather than by expert review of patient cases.

4. Adjudication Method for the Test Set

This is not applicable as the "ground truth" for the method agreement study was derived from another device's measurements, not from expert consensus or adjudication of clinical findings.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) immunoassay, which does not typically involve human readers interpreting results in the same way imaging devices do. The comparison was between two different assay methodologies (EIA vs. RIA).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The entire study describes the performance of the new Monobind Microplate EIA device as a standalone analytical tool, comparing its T3 measurements to those obtained from a predicate RIA device. There is no human intervention in the measurement process of the assay itself once the sample is added.

7. The Type of Ground Truth Used

The ground truth for the method agreement study was established using the measurements from a predicate device: the Monobind total trilodothyronine (T3) coated tube radioimmunoassay (RIA). For recovery and linearity studies, the ground truth was based on the known concentrations of added exogenous triiodothyronine or theoretical concentrations after dilution.

8. The Sample Size for the Training Set

The submission does not specify a separate training set. For in vitro diagnostic assays like this, the "training" (calibration curve generation) is typically part of the assay procedure using defined calibrators, and the clinical performance evaluation is done on a separate set of patient samples. The 120 specimens were used for the clinical comparison/validation study, which serves as the "test set."

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

As no separate training set as typically understood in machine learning was mentioned, the method for establishing ground truth for a training set is not applicable. The device uses "identically prepared calibrators" which would have known T3 concentrations, and these are used to establish the dose-response curve for the assay. The ground truth for these calibrators would be established through a rigorous measurement and validation process by the manufacturer, typically traceable to international reference standards if available.

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