(157 days)
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
The ELECSYS® Anti-Tg Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.
The provided text describes the ELECSYS® Anti-Tg Assay, an immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma, used as an aid in detecting autoimmune thyroid diseases.
This submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating comparable performance to an existing device rather than establishing new acceptance criteria based on a standalone clinical study. Therefore, the information typically requested for AI/ML device studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies) is not directly applicable in the same way to this conventional immunoassay submission.
Instead, the "acceptance criteria" here refer to the performance characteristics that demonstrate substantial equivalence to the predicate device. The "study" proving the device meets these criteria is the comparative performance testing against the predicate device.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" are implied by the performance characteristics of the predicate device, which the new device aims to be substantially equivalent to. The robust performance data from the predicate device serves as the benchmark.
| Feature | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (ELECSYS® Anti-Tg) |
|---|---|---|
| Measuring range | 0 – 3000 IU/ml | 10 – 4000 IU/ml |
| Expected values | Nondetectable to 40 IU/ml (95th percentile) | Up to 115 IU/ml (95th percentile) |
| Intra-assay precision (%CV) | Ranges from 3.2% to 4.9% | Ranges from 4.6% to 5.6% |
| Total precision (%CV) | Ranges from 4.6% to 5.8% | Ranges from 5.9% to 8.7% |
| Analytical sensitivity | 2.2 IU/ml |
§ 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).