(529 days)
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
Access Thyroqlobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent /metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thvroglobulin antibodies.
The Access Tg assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Tg sample diluent substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The device modification described in this submission impacts the Access Thyroqlobulin reagent pack only; the change does not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidin |
| and coupled to biotinylated mouse monoclonal | |
| antithyroglobulin antibodies, suspended in a TRIS buffer with | |
| protein (bovine), |
The provided text describes the Beckman Coulter Access Thyroglobulin assay, a chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum. This device is intended to aid in monitoring for persistent or recurrent/metastatic differentiated thyroid cancer (DTC) in patients who have undergone thyroid surgery and lack serum thyroglobulin antibodies.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported performance for all aspects. Instead, acceptance criteria are generally mentioned within the description of each study. Below is a compilation of the criteria and reported performance for key studies.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | R ≥ 0.90 and slope 1.00 ± 0.09 | Met (R and slope not explicitly provided but stated as met) |
| High-dose Hook Effect | No high-dose hook effect | No high-dose hook effect at concentrations up to at least 40,000 ng/mL |
| Reference Range | Linear across the range of the assay | Linear across the range of the assay (0.1 to approximately 500 ng/mL) |
| Limit of Blank (LoB) | ≤ 0.03 ng/mL | 0.02 ng/mL |
| Limit of Detection (LoD) | ≤ 0.05 ng/mL | 0.05 ng/mL |
| Limit of Quantitation (LoQ) | ≤ 0.1 ng/mL | 0.05 ng/mL |
| Analytical Specificity (Cross-reactivity) | Change in concentration between diluent control and test samples within ± 10% | No significant cross-reactivity for T3, T4, TBG, TSH |
| Analytical Specificity (Interference) | Change in concentration between diluent control and test samples within |
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.