(104 days)
For the quantitative detection of IqG antibodies to thyroid peroxidase in human serum by enzyme immunoassay. The SeraQuest Anti-thyroid peroxidase test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease. For in vitro diagnostic use only.
The SeraQuest Anti-Thyroid Peroxidase test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minutes incubations. It has been developed to detect IgG antibodies which are directed against Thyroid Peroxidase, in human serum. The Calibrators in the SeraQuest Anti-Thyroid Peroxidase test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).
Here's a breakdown of the acceptance criteria and the study details for the SeraQuest® Anti-Thyroid Peroxidase device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" but rather presents a clinical study comparing the new device (SeraQuest) against a predicate device (Varelisa TPO Antibodies test). The performance metrics of the SeraQuest device against the predicate are what would typically be used to demonstrate equivalence for regulatory acceptance.
| Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (SeraQuest vs. Varelisa) |
|---|---|---|
| Relative Sensitivity | High (e.g., comparable to predicate) | 100% (95% CI: 99.9-100%) |
| Relative Specificity | High (e.g., comparable to predicate) | 99.1% (95% CI: 97.7-100%) |
| Overall Agreement | High (e.g., comparable to predicate) | 99.2% (95% CI: 97.3-100%) |
Note: The document states, "The SeraQuest Anti-Thyroid Peroxidase test is substantially equivalent in intended use and performance, to the Pharmcia Varelisa TPO Antibodies, Freiburg, Germany." This indicates that the performance of the predicate device serves as the implicit acceptance criteria for the new device.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 141 serum specimens.
- Data Provenance: The study was conducted at Quest International, Inc., implying the data was collected or processed within the United States. The retrospective or prospective nature of the sample collection is not explicitly stated, but the specimens were "tested concurrently" by both devices, suggesting a prospective application to existing samples or a concurrent collection setup.
3. Number and Qualifications of Experts for Ground Truth
- The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., a panel of radiologists for imaging).
- Instead, the "ground truth" for the performance evaluation was established by comparing the SeraQuest device's results against a legally marketed predicate device, the Pharmacia Varelisa TPO Antibodies test. The predicate device itself acts as the reference standard.
4. Adjudication Method for the Test Set
- No explicit adjudication method (like 2+1, 3+1) is described for the test set.
- The comparison was a direct concurrent testing of each specimen by both the SeraQuest device and the Varelisa TPO Antibodies test, with results compared qualitatively (positive, equivocal, negative). For discordant results, one specimen was re-tested using a second legally marketed device (Scimedix Anti-Thyroid Peroxidase Test) to help resolve the discrepancy, but this wasn't a systematic adjudication process for all disagreements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test, not an imaging AI tool requiring human reader interpretation or assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done in the sense that the SeraQuest device's results were independently generated for each specimen and then compared to the predicate. The performance metrics (sensitivity, specificity, agreement) directly reflect the algorithm's (or device's) standalone diagnostic capabilities relative to the predicate. There is no human-in-the-loop component for these specific performance metrics.
7. Type of Ground Truth Used
- The ground truth used was the results obtained from a legally marketed predicate device (Pharmacia Varelisa TPO Antibodies test). For one discordant case, a second legally marketed device (Scimedix Anti-Thyroid Peroxidase Test) was used as an additional reference. This is a form of comparative ground truth against an established, similar diagnostic method.
8. Sample Size for the Training Set
- The document does not provide information on a training set or its sample size. This is typical for IVD assay submissions where the focus is on analytical and clinical performance against a reference method rather than AI algorithm training.
9. How Ground Truth for the Training Set Was Established
- Since no training set is mentioned, information on how its ground truth was established is not provided.
§ 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).