(63 days)
The Nichols Advantage™ Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay is intended for use on the Nichols Advantage™ Specialty System for the quantitative determination of Thyroid Peroxidase Autoantibodies (TPOAb) in human serum as an aid in the diagnosis and assessment of patients with autoimmune thyroid disease.
The Nichols Advantage™ Anti-TPO is a two-site chemiluminescence assay for use with the Nichols Advantage™ Specialty System
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them, presented in the requested format:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each performance characteristic. However, by comparing the performance of the new device (Nichols Advantage™ Chemiluminescence Anti-TPO) to the predicate device (Nichols Institute Diagnostics Chemiluminescence Anti-TPO), it can be inferred that the performance of the new device should at least be comparable to or better than the predicate, or meet established laboratory standards for clinical assays. For the purpose of this analysis, the predicate device's performance will be used as a reference point for implicit acceptance.
| Feature | Acceptance Criteria (Implied from Predicate/General Lab Standards) | Reported Device Performance (Nichols Advantage™) |
|---|---|---|
| Intra-Assay Precision | %CV values comparable to or lower than predicate (e.g., 4,000 IU/mL | |
| Specificity/Cross-Reactivity | No interference from common autoantibodies/thyroglobulin | Undetectable (Anti-Thyroglobulin, Thyroglobulin) |
| Method Comparison | Preliminary Reference Range established | Normal |
§ 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).