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UniCAP Thyroglobulin ImmunoCAP™ is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. UniCAP Thyroglobulin ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP Thyroid Peroxidase ImmunoCAP is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPO) in human serum and plasma. UniCAP Thyroid Peroxidase ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP Specific IgG is an in vitro test system for the quantitative and qualitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP™ solid phase component of the UniCAP Specific IgG System. UniCAP Specific IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

UniCAP Thyroglobulin IgG Antibodies Controls are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin in human serum. UniCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument UniCAP.

UniCAP Thyroid Peroxidase IgG Antibodies Controls are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase in human serum. UniCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument UniCAP.

UniCAP Immunodiagnostic System is a fully integrated and automated system for immunodiagnostic testing. UniCAP System is comprised of Instruments (UniCAP 100 Analyzer. Test System Modules and Assay Products (Fluororenzymeimmunoassays for the measurement of IgE, IgG), ImmunoCAP™ Antigens (solid phase components which contain the specific antigens to be measured), and Software Accessories.

UniCAP 100 Analyzer is designed to handle all steps from sample and reagents handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.

UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs. Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software.

UniCAP 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer or network server.

UniCAP Specific IgG is a fluoroenzymeimmunoassay for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP™ solid phase component. Specific IgG antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission, Thyroglobulin and Thyroid Peroxidase, which are covalently coupled to ImmunoCAP.

The UniCAP Thyroid Peroxidase ImmunoCAP contains recombinant human Thyroid Peroxidase covalently coupled to a cellulose matrix. The UniCAP Thyroglobulin ImmunoCAP contains purified human Thyroglobulin covalently coupled to the cellulose matrix.

Here's a breakdown of the acceptance criteria and study details based on the provided text, focusing on the UniCAP® Thyroglobulin IgG Assay and UniCAP® Thyroid Peroxidase IgG Assay:

The submission describes a comparison study performed to demonstrate substantial equivalence to a legally marketed predicate device, rather than establishing de novo performance characteristics against a clinical ground truth. Therefore, the "acceptance criteria" are implicitly met by demonstrating strong correlation with the predicate device.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and data provenance:

   • Sample Size: 100 serum samples for UniCAP® Thyroglobulin IgG Assay and 100 serum samples for UniCAP® Thyroid Peroxidase IgG Assay.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only states "100 serum samples were collected".

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The ground truth was established by comparing the device's results to a legally marketed predicate device (Varelisa® TG Antibody Assay and Varelisa® TPO Antibody Assay) rather than expert consensus on patient conditions.

3. Adjudication method for the test set:

   • Not applicable. The study involved a direct comparison of quantitative measurements from two different assay systems.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is an in vitro diagnostic device for quantitative measurement of antibodies, not an imaging or diagnostic aid for human interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this was a standalone performance study. The UniCAP® assays were run independently, and their results were compared to the results from the predicate Varelisa® assays.

6. The type of ground truth used:

   • Reference device/predicate device performance: The "ground truth" for this substantial equivalence study was the results obtained from the legally marketed predicate devices: Varelisa® Thyroglobulin Antibodies Assay and Varelisa® Thyroid Peroxidase Antibodies Assay.

7. The sample size for the training set:

   • Not applicable. This is a medical device submission for an in vitro diagnostic assay, not a machine learning or AI-based device that typically involves training sets. The assessment is based on direct performance comparison.

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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UniCAP Thyroglobulin ImmunoCAP™ is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. UniCAP Thyroglobulin ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP Thyroid Peroxidase ImmunoCAP is a device for the in vitro quantitative measurement of IgG antibodies specific for Thvroid Peroxidase (TPO) in human serum and plasma. UniCAP Thyroid Peroxidase ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions For Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, and Graves' Disease and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP Specific IgG is an in vitro test system for the quantitative and qualitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP™ solid phase component of the UniCAP Specific IgG System. UniCAP Specific IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

UniCAP Thyroglobulin IgG Antibodies Controls are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin in human serum. UniCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument UniCAP.

UniCAP Thyroid Peroxidase IgG Antibodies Controls are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxicase in human serum. UniCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument UniCAP.

UniCAP Immunodiagnostic System is a fully integrated and automated system for immunodiagnostic testing. UniCAP System is comprised of Instruments (UniCAP 100 Analyzer, Test System Modules and Assay Products (Fluororenzymeimmunoassays for the measurement of IgE, IgG). ImmunoCAP™ Antigens (solid phase components which contain the specific antigens to be measured), and Software Accessories.

UniCAP 100 Analyzer is designed to handle all steps from sample and reagents handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.

UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software.

UniCAP® 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer or network server.

UniCAP Specific IgG is a fluoroenzymeimmunoassay for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP™ solid phase component. Specific IgG antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission, Thyroglobulin and Thyroid Peroxidase, which are covalently coupled to ImmunoCAP.

The UniCAP Thyroid Peroxidase ImmunoCAP contains recombinant human Thyroid Peroxidase covalently coupled to a cellulose matrix. The UniCAP Thyroglobulin ImmunoCAP contains purified human Thyroglobulin covalently coupled to the cellulose matrix.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in terms of numerical thresholds for correlation coefficients or regression equations. Instead, the acceptance criterion for both UniCAP Thyroglobulin IgG Assay and UniCAP Thyroid Peroxidase IgG Assay is implicitly defined as "substantially equivalent" to their respective legally marketed predicate devices (Varelisa® Thyroglobulin Antibodies Assay and Varelisa® Thyroid Peroxidase Antibodies Assay). This substantial equivalence is demonstrated through a comparison study and statistical analysis.

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

• Test Set Sample Size: 100 serum samples for UniCAP Thyroglobulin IgG Assay and 100 serum samples for UniCAP Thyroid Peroxidase IgG Assay.
• Data Provenance: The document does not specify the country of origin for the serum samples. It is a retrospective study using collected serum samples to compare the new device against the predicate device.

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 to this submission. For in vitro diagnostic (IVD) assays like the UniCAP series, the "ground truth" for the test set is established by the measurements obtained from the predicate device (Varelisa® assays in this case), and the study aims to show correlation with those established measurements. There are no human experts "establishing ground truth" in the way one might for an imaging AI device.

4. Adjudication Method for the Test Set

Not applicable. The study design is a direct comparison of quantitative measurements from two different assay systems (new device vs. predicate device) on the same serum samples. There is no human adjudication process involved in comparing the results of the two assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This submission is for an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study and effects on human reader performance are not relevant.

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

Yes, effectively. The performance described is for the UniCAP assays operating in a "standalone" manner, meaning the device itself measures the antibodies in serum samples and provides a quantitative result. There is no explicit "human-in-the-loop" component for interpretation described in the performance study, beyond the standard operation of an IVD system by laboratory personnel. The device's output (quantitative measurement) is directly compared to the predicate device's output.

7. The Type of Ground Truth Used

The ground truth or reference standard for this study is the measurements obtained from the legally marketed predicate devices:

• Varelisa® Thyroglobulin Antibodies Assay for the UniCAP Thyroglobulin IgG Assay.
• Varelisa® Thyroid Peroxidase Antibodies Assay for the UniCAP Thyroid Peroxidase IgG Assay.

The study aims to demonstrate that the new devices' results are in close statistical agreement (correlation) with these established methods.

8. The Sample Size for the Training Set

Not explicitly stated/Not applicable in the conventional sense. For IVD assays, "training set" doesn't typically refer to a data set used to train an AI algorithm. Instead, the development and verification process for IVDs involve method validation studies (e.g., linearity, precision, interference) and internal studies using various samples to establish performance characteristics. The submission does not detail the sample sizes used for these internal development and validation phases. The specific "comparison study" sample sizes are for demonstrating substantial equivalence.

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

Since there is no "training set" in the context of machine learning, this question for an IVD assay is not applicable. The "ground truth" for an IVD's development would stem from clinical studies, established reference methods, and clinical relevance to disease states, which are part of the broader development process for any diagnostic test. For the comparison study, the predicate device serves as the reference.

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