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VITROS Free T3 Reagent Pack For in vitro diagnostic use only. The VITROS Free T3 Reagent Pack quantitatively measures free triodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease.

VITROS Free T3 Calibrators - For in virro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin)

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Free T3 Reagent Pack, VITROS Immunodiagnostic Products Free T3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Free T3 assay.
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text describes a 510(k) submission for a new formulation of the VITROS Immunodiagnostic Products Free T3 Reagent Pack and Free T3 Calibrators. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the study as described, specifically addressing the points requested and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., specific thresholds for accuracy, precision, correlation). Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The study's reported performance is a comparison of characteristics and the overall conclusion of equivalence.

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

The document states: "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range." However, the specific sample size used for the test set is not provided.

The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated. It can be inferred that the samples are human given the intended use "in human body fluids."

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

This type of information is generally not applicable or discussed for in vitro diagnostic (IVD) assays, particularly those measuring analytes like Free T3. The "ground truth" for an IVD device is typically established by laboratory reference methods or comparison to a predicate device's established values, not by human expert interpretation of images or clinical assessments in the same way as an AI-powered diagnostic imaging tool. Therefore, this information is not present in the document.

4. Adjudication Method for the Test Set

As explained in point 3, the concept of expert adjudication in the context of diagnostic performance for an assay like Free T3 is not typically relevant. The comparison is based on quantitative measurements. Therefore, no adjudication method is described or applicable.

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 done. This type of study is relevant for diagnostic imaging interpretation where human readers are involved. For an automated in vitro diagnostic assay, an MRMC study is not applicable.

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

This device is an in vitro diagnostic assay, which by its nature operates "standalone" in the sense that it performs a chemical analysis to produce a quantitative result without direct human interpretation of the underlying signal in the way an imaging algorithm does. The "algorithm" here is the chemical reaction and detection process. The documentation describes the performance of this system.

While a human clinician interprets the final numerical result, the device itself provides the measurement without human-in-the-loop performance during the assay execution. Therefore, the performance described is inherently "standalone" for the assay's function.

7. The Type of Ground Truth Used

The "ground truth" for this study is essentially the results obtained from the predicate device (VITROS Immunodiagnostic Products Free T3 assay, original formulation).

The document states: "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range." This implies that the new formulation's readings on these patient samples were compared against the established readings of the predicate device on the same samples.

8. The Sample Size for the Training Set

The document does not specify a training set size or mention a distinct "training set" in the context of device development or validation. For chemical assays like this, performance is validated through analytical studies (precision, accuracy, linearity, interference, etc.) rather than "training" an AI model.

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

As there is no mention of a training set in the context of machine learning or AI, this information is not applicable and not provided. The "ground truth" for the predicate device's original establishment would have been through its own rigorous validation studies against reference methods, but this is not detailed for the new formulation's submission which focuses on substantial equivalence.

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DPC's IMMULITE® Free T3 is a chemiluminescent assay for use with the IMMULITE® Automated Immunoassay Analyzer and is designed for the quantitative measurement of Free T3 in serum. It is intended strictly for in vitro diagnostic use as an aid in clinical assessment of thyroid status.

Free T3 is a solid-phase, IMMULITE® Chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Immunoassay Analyzer.

Here's a breakdown of the acceptance criteria and study information for the Diagnostic Products Corporation IMMULITE® Free T3 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a pass/fail format for a primary outcome. Instead, it demonstrates performance by comparing the IMMULITE® Free T3 assay to a legally marketed predicate device (Chiron Diagnostics' ACS:180 Free T3) through a method comparison. The acceptance is implied by the "substantial equivalence" determination by the FDA.

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

• Sample Size: 237 patient samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "patient samples," which typically implies prospective or retrospective collection from a clinical setting, but it's not specified. It is a retrospective study since it compares the device to an existing predicate device.

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

This information is not provided in the document. The study is a method comparison against a predicate device, not a diagnostic accuracy study establishing ground truth based on expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a method comparison between two assays, not a diagnostic performance study requiring adjudication of expert interpretations.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the analytical performance of the new device compared to an existing one.

6. Standalone (Algorithm Only) Performance Study

This is an in vitro diagnostic (IVD) device, not an algorithm in the typical sense of AI. The performance reported is the standalone performance of the IMMULITE® Free T3 assay in direct comparison with the ACS:180 Free T3 assay. There is no human-in-the-loop component described for its operation or interpretation beyond the standard laboratory workflow.

7. Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the predicate device (Chiron Diagnostics' ACS:180 Free T3 assay). The study aims to demonstrate that the new IMMULITE® Free T3 assay provides comparable results to an already legally marketed and established assay for free T3 measurement.

8. Sample Size for the Training Set

This information is not provided and is largely not applicable in the same way it would be for a machine learning algorithm. The IMMULITE® Free T3 device is a chemiluminescent immunoassay, and its "training" or optimization would involve laboratory development and calibration, not a traditional machine learning training set. The standard curve (mentioned as "stored" and "calibrated") is analogous to a training phase in a broader sense, but the specific sample size for its establishment is not detailed.

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

Similar to point 8, this information is not explicitly detailed in the document. For an immunoassay, the "ground truth" for calibration curves is typically established using a series of known concentration standards of free T3. These standards would be meticulously prepared and verified to ensure accurate calibration of the assay.

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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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