(63 days)
The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of autoantibodies against thyroglobulin (TG) in human serum and plasma for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are intended for use in the diagnosis of Hashimoto's and Graves' autoimmune diseases affecting the thyroid gland.
The ACS:180 and ADVIA Centaur anti-Tg are a competitive chemiluminescence immunoassay intended for the quantitative determination of autoantibodies against thyroglobulin in human serum and plasma. A polyclonal human anti-Tg antibody is bound to a solid phase. Patient samples, standards, and controls are incubated with labeled native human thyroglobulin. Autoimmune anti-thyroglobulin antibodies in patient samples compete with the solid phase antibody for the labeled thyroglobulin. Following incubation, unreacted labeled thyroglobulin and unreacted antibodies from the sample are removed by washing. The chemiluminescence of the reacted, labeled thyroglobulin bound to the solid phase is measured in a luminometer. The amount of chemiluminescence is inversely proportional to the concentration of anti-thyroglobulin antibody in the sample.
Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the supporting study:
The provided document describes the Bayer Diagnostics ACS:180 and ADVIA Centaur anti-Tg Immunoassay, seeking substantial equivalence to the predicate device DYNOTest® anti-Tgn. The acceptance criteria are implicitly defined by demonstrating substantial equivalence through specific performance targets, primarily agreement percentages with the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the documented comparison studies against the predicate device. While explicit "acceptance criteria" are not listed as numerical thresholds, substantial equivalence is claimed based on the achieved agreement percentages.
| Performance Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported ACS:180 Performance (vs. DYNOTest anti-Tgn) | Reported ADVIA Centaur Performance (vs. ACS:180) |
|---|---|---|---|
| Overall Agreement | Statistically significant agreement for substantial equivalence | 97.6% (286/293) for Normal Patients | 98% (250/255) |
| 87.9% (87/99) for Graves Patients | |||
| 70.9% (134/189) for Hashimoto's Patients | |||
| Correlation Coefficient (r) | N/A (for ACS:180 vs. DYNOTest) | N/A | 0.989 |
| Sensitivity (vs predicate) | Greater sensitivity is a positive indicator (not a firm threshold) | Graves: 39.9% (ACS:180) vs. 29.3% (DYNOTest) | N/A |
| Hashimoto's: 70.4% (ACS:180) vs. 41.2% (DYNOTest) | N/A |
2. Sample Sizes and Data Provenance
The study involved two main comparisons:
- ACS:180 vs. DYNOTest anti-Tgn (Predicate device):
- Test Set Sample Size:
- Normal patients: 293 samples
- Graves patients: 99 samples
- Hashimoto's patients: 189 samples
- Total for this comparison: 581 samples
- Data Provenance: Not explicitly stated (e.g., country of origin). The study design appears to be retrospective, using collected serum samples.
- Test Set Sample Size:
- ADVIA Centaur vs. ACS:180 (Transference Study):
- Test Set Sample Size: 255 serum samples (in the range of 10 to 500 U/mL)
- Data Provenance: Not explicitly stated, likely retrospective.
3. Number of Experts and their Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "ground truth" for the comparison study appears to be defined by the results of the predicate device (DYNOTest anti-Tgn), which itself would have been established through clinical validation involving medical expertise, but this document does not detail the predicate's ground truth establishment.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The comparisons are presented as direct agreements between the devices' classifications (positive/negative) against each other, rather than against an external gold standard that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This submission pertains to in vitro diagnostic (IVD) immunoassays, which are laboratory tests measuring biomarkers, not imaging or subjective diagnostic assessments that typically involve multiple human readers. Therefore, an MRMC study is not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes, in essence. The entire comparison study for both the ACS:180 and ADVIA Centaur devices against their predicate or each other constitutes a standalone performance evaluation. Immunoassays are "algorithm only" in the sense that they provide quantitative results based on chemical reactions and signal detection, without human interpretation of subjective data like images. The reported agreement percentages reflect the standalone performance of the devices relative to other devices.
7. Type of Ground Truth Used
- Type of Ground Truth: The primary "ground truth" for demonstrating substantial equivalence for the new devices (ACS:180 and ADVIA Centaur) is the results of the legally marketed predicate device (DYNOTest anti-Tgn).
- For the patient classifications (Normal, Graves, Hashimoto's), these types of diagnoses are typically confirmed through a combination of clinical assessment, other laboratory tests, imaging, and sometimes pathology or long-term outcomes, but the document implicitly uses the predicate device's findings as the reference for the comparison.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. For IVD devices, a "training set" in the machine learning sense is not typically applicable. Instead, method development (optimization of reagents, conditions, algorithms for signal processing) is performed using various samples, but these are not explicitly termed "training sets" with specific sizes in this context. The document focuses on the validation and comparison of the final device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no explicitly defined "training set" with a described ground truth establishment process in this submission. The development and optimization of such assays involve internal testing and refinement, but this information is not detailed within this 510(k) summary.
§ 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).