(83 days)
The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroqlobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroglobulin Antibody II assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with the thyroglobulin protein. The TgAb in the sample binds to the thyroglobulin coated on the particles. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The thyroglobulin-alkaline phosphatase conjugate is added and binds to the TgAb.
After second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Here's a detailed breakdown of the acceptance criteria and study information for the Beckman Coulter Access Thyroglobulin Antibody II device, extracted from the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Device - Dxl 9000 Access Immunoassay Analyzer) |
|---|---|---|
| Intended Use | Quantitative determination of thyroglobulin antibody levels in human serum and plasma to aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease. | Same (No change in Intended Use) |
| Analyte Measured | Thyroglobulin Antibody | Same |
| Technology / Format / Method | Sandwich immunoassay / Chemiluminescent / Automated | Same |
| Sample Type | Human serum or plasma | Same |
| Sample Volume | 10 uL | Same |
| Measuring Range | 1.5 - 2,500 IU/mL | Same |
| Blocker Reagents | Biotin and alkaline phosphatase included in reagent pack as blockers | Same |
| Biotin Interference | No significant interference (± 10%) observed in samples containing up to 3,510 ng/mL of biotin. | Same (Explicitly stated in the comparison table) |
| Imprecision (Repeatability) | SD ≤ 1.5 for values |
§ 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).