(259 days)
ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease.
The ARCHITECT® Anti-Tg Calibration of the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
The ARCHITECT® Anti-Tg Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument) when used for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
The ARCHITECT Anti-Tg assay is a two-step immunoassay for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.
In the first step, sample, assay diluent and Tg coated paramagnetic microparticles are combined and incubated. Anti-Tg present in the sample binds to the Tg coated microparticles. After washing, anti-human IgG acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-Tg in the sample and the RLUs detected by the ARCHITECT i system optics.
The ARCHITECT® Anti-Tg assay is a device for the quantitative determination of IgG class thyroglobulin autoantibodies (anti-Tg) in human serum and plasma, intended as an aid in the diagnosis of thyroid disease.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the ARCHITECT® Anti-Tg assay demonstrated substantial equivalence to the predicate device, the Nichols Advantage Thyroglobulin Autoantibodies Assay, based on various performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Substantially equivalent to predicate | Substantially equivalent to predicate |
| Linearity | Substantially equivalent to predicate | Substantially equivalent to predicate |
| Interferences | Substantially equivalent to predicate | Substantially equivalent to predicate |
| Stability | Substantially equivalent to predicate | Substantially equivalent to predicate |
| Method Concordance (NCCLS Standard EP-12A) | Substantially equivalent to predicate | Substantially equivalent to predicate |
| Sample Stability (Lithium Heparin & Serum Separator tubes) | No systematic gain or loss of detectability | No systematic gain or loss of detectability |
2. Sample size used for the test set and the data provenance:
The document mentions a "summary clinical performance" study and a "method concordance using the NCCLS Standard (EP-12A)". However, the sample size for the test set is not explicitly stated. The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study focuses on comparing the new device against a predicate device, rather than establishing a de novo ground truth with expert consensus.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an immunoassay system for laboratory analysis, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance described is inherently a "standalone" or "algorithm-only" performance in the context of an automated immunoassay system. The document reports non-clinical performance (precision, linearity, interferences, stability) and clinical performance (method concordance, sample stability) where the device's output is compared to the predicate device. There is no human-in-the-loop interaction for interpretation in the same way as, for example, an AI-powered image analysis tool.
7. The type of ground truth used:
The "ground truth" for the comparison studies was implicitly established by the results of the legally marketed predicate device, the Nichols Advantage Thyroglobulin Autoantibodies Assay. The goal was to demonstrate substantial equivalence to this existing device.
8. The sample size for the training set:
This information is not applicable as this is an immunoassay system, not a machine learning or AI-based device that typically requires a separate training set. The device uses established biochemical principles for measurement.
9. How the ground truth for the training set was established:
This question is not applicable for the same reason as point 8.
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).