(320 days)
ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® i System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease.
The ARCHITECT® Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serion and plasma.
The ARCHITECT® Anti-TPO 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 thyroid peroxidase autoantibodies (anti-TPO) in human ser im and plasma.
The ARCHITECT Anti-TPO assay is a two-step immunoassay for the quantitative determination of anti-TPO in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Cherriflex® In the first step, sample, assay diluent and TPO coated paramagnetic microparticles are combined and incubated. Anti-TPO present in the sample binds to the TPO coated microparticles. After washing, anti-human IGG acridinium labeled conjugate is added in the second step. Following and wash, herearinger and trigger solutions are added to the reaction mixture. The resulting chemiluminessent reaction is measured as relative light units (RLU). A direct relationship exists between the amount of anti-TPO in the samble and the RLUs detected by the ARCHITECT i system optics.
The provided text describes a 510(k) submission for the ARCHITECT® Anti-TPO Immunoassay, which is a medical device for the quantitative determination of anti-TPO antibodies. The document focuses on demonstrating substantial equivalence to a predicate device, the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA).
Here's an analysis of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criterion for substantial equivalence in this context is method concordance between the new device and the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Abbott AxSYM®) | Demonstrated via clinical performance and method concordance (92.6%) |
| Precision | Demonstrated as substantially equivalent to predicate |
| Linearity | Demonstrated as substantially equivalent to predicate |
| Interferences | Demonstrated as substantially equivalent to predicate |
| Stability | Demonstrated as substantially equivalent to predicate |
Study Information
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Sample sizes used for the test set and the data provenance:
The document states that a "method concordance using the NCCLS Standard (EP-12A) was also conducted". However, it does not provide the specific sample size used for this clinical performance study or the geographical origin of the data. It is implicitly a retrospective study comparing a new method to an existing one using collected samples. -
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. For an immunoassay, the "ground truth" often refers to the results obtained from a reference method or a well-established predicate device. The document uses the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) as the predicate for comparison, implying this served as the reference for establishing concordance. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication typically applies to studies where human reviewers independently assess data and their discrepancies are resolved. In this case, it's a comparison of automated immunoassay results. -
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 is not applicable as the device is an automated immunoassay system, not an AI-assisted diagnostic tool that involves human readers' interpretation of images or other data. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance presented for the ARCHITECT® Anti-TPO assay is its standalone performance as an automated immunoassay. The comparison is made purely between the results generated by the ARCHITECT® system and the predicate AxSYM® system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the results obtained from the legally marketed predicate device, the Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA). The new device's results are compared against this established method to demonstrate substantial equivalence. -
The sample size for the training set:
This information is not provided and is generally not applicable in the context of a traditional immunoassay device. Immunoassays are based on biochemical reactions and established protocols, not machine learning models that require training sets in the same way. -
How the ground truth for the training set was established:
As mentioned above, this is not applicable in the context of this immunoassay device.
§ 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).