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510(k) Data Aggregation
(49 days)
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems.
The detection of TPO antibodies is an aid in the diagnosis of thyroid autoimmune disorders.
The Access TPO Antibody reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of thyroperoxydase antibody (TPO) levels in human serum and plasma.
Here's a breakdown of the acceptance criteria and the study details for the provided device, based on the input text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Imprecision (Within-run CV) | Ranged from 2.6% CV to 7.9% CV for concentrations from approximately 0.6 to 809 IU/mL. | Analytical Study |
| Imprecision (Between-run CV) | Ranged from 1.3% CV to 4.9% CV. | Analytical Study |
| Imprecision (Total CV) | Ranged from 3.1% CV to 8.7% CV. | Analytical Study |
| Dilution Recovery (Linearity) | Mean % recovery ranged from 86.4% to 94.9%. Note: "Due to varying antigen specificity, and avidity of TPOAb in their epitope reactions, some samples may not dilute linearly." | Analytical Study |
| Methods Comparison (Against a commercially available immunoassay system) | Range of observations: 5-1000 | |
| Slope: 1.0207 (95% confidence interval 0.9722 to 1.0693) | ||
| Intercept: -10.9123 (95 % confidence interval -24.6421 to 2.8175) | ||
| Correlation coefficient (r): 0.97 | ||
| Results indicate the slope and intercept are not significantly different from one and zero respectively. | Analytical Study | |
| Analytical Specificity (Interference from potential sample contaminants) | No significant interference from bilirubin, hemoglobin, human serum albumin, and triglycerides. | Analytical Study |
| Stability (TPOAb reagents) | Stable for 56 days after opening. | Analytical Study |
| Stability (TPOAb calibrators) | Stable for 120 days after opening. | Analytical Study |
| Stability (Calibration) | Stable for 56 days. | Analytical Study |
| **Expected/Normal Reference Range (Healthy males |
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