(60 days)
ImmunoCAP Thyrodlobulin is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. ImmunoCAP Thyroglobulin is intended to be used with the ImmunoCAP 100° and ImmunoCAP 250 instruments. 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 physicians office laboratories.
ImmunoCAP Thyroid Peroxidase is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPO) in human serum and plasma. ImmunoCAP Thyroid Peroxidase is intended to be used with the ImmunoCAP 100C and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, Graves' disease and is to be used in clinical laboratories, as well as physicians office laboratories.
ImmunoCAP Thyroglobulin IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroglobulin antibodies in human serum. ImmunoCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100° and ImmunoCAP 250.
ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroid Peroxidase antibodies in human serum. ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100€ and ImmunoCAP 250.
The modified devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using ImmunoCAP single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the ImmunoCAP IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.
The provided document is a 510(k) Summary for the ImmunoCAP™ Thyroglobulin and ImmunoCAP™ Thyroid Peroxidase immunological test systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria and proving performance against them from scratch. Therefore, many of the requested details about a study proving the device meets acceptance criteria are not explicitly stated in the document in the format one might expect for a de novo device submission.
However, based on the information provided, here's an attempt to answer the questions, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantified acceptance criteria or reported device performance in a table format. Instead, it relies on demonstrating laboratory equivalence to previously cleared predicate devices (UniCAP TG Antibodies K981559 and UniCAP TPO Antibodies K981930). The "acceptance criteria" can be inferred as successful comparability and substantial equivalence to these predicates.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (UniCAP TG Antibodies K981559, UniCAP TPO Antibodies K981930) | "all available data support that the modified devices are substantially equivalent to the previously cleared devices." This is based on: Comparison studies between modified and previously cleared devices.Results obtained for clinically defined sera.Results obtained for samples from apparently healthy subjects (normal population). |
| Reduction of interference from cellulose IgG antibodies | Device modification includes "the addition of a blocking diluent to reduce interference from cellulose IgG antibodies" (implied successful). |
| Compatibility with ImmunoCAP 100 and ImmunoCAP 250 instruments | The device is intended to be used with these instruments. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the comparison studies or the provenance of the data (e.g., country of origin, retrospective/prospective). It mentions:
- "results obtained for clinically defined sera"
- "results obtained for samples from apparently healthy subjects (normal population)"
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The ground truth for "clinically defined sera" and "apparently healthy subjects" is typically established through clinical diagnosis and standard laboratory tests, but the involvement of specific experts or their qualifications is not detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) 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
A multi-reader multi-case (MRMC) comparative effectiveness study is not relevant to this type of in vitro diagnostic device, which is an automated immunoassay system measuring specific IgG antibodies. This is not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone in vitro diagnostic system. The "algorithm" here refers to the immunoassay's reaction and instrument's software for evaluation. The document implicitly supports its standalone performance because the "instruments ImmunoCAP 100° and ImmunoCAP 250... include software for evaluation of test results." The equivalence studies described are effectively standalone performance assessments against predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document refers to "clinically defined sera" and "samples from apparently healthy subjects." This suggests the ground truth was based on clinical diagnoses (which could involve a combination of expert assessment, other laboratory tests, and potentially patient outcomes) rather than a single source like pathology for tissue samples.
8. The sample size for the training set
This information is not provided. As this is a modification of an existing device and focuses on demonstrating equivalence, detailed training set information is less likely to be presented than for a de novo AI/ML device. The "training" in this context would typically refer to the development and optimization of the immunoassay itself, not a machine learning model.
9. How the ground truth for the training set was established
This information is not explicitly provided. Similar to the test set, the ground truth for developing and optimizing the assay (if considered a "training set") would likely involve clinically characterized samples, but the method of establishment is not detailed.
§ 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).