(39 days)
The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay intended for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.
The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.
The method for the quantitative determination of TSH is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely related to TSH concentration present in calibrators, patient samples or controls.
The LIAISON® Control Thyroid 1, 2 and 3 are prepared from human serum at target values of 0.5-0.78 mIU/L. 7.0-9.48 mIU/L and 42.7-57.7 mIU/L.
The provided document describes the DiaSorin LIAISON® TSH assay, an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum, and associated quality controls (LIAISON® Control Thyroid 1, 2, and 3). The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" but rather describes various performance characteristics and their results, which serve as evidence of the device meeting certain performance standards for substantial equivalence. I will infer the acceptance criteria from the context of typical lab assay performance and the results presented.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Method Comparison | Good agreement with a commercially available immunoassay (predicate device or similar). Typically, R² near 1, slope near 1, and intercept near 0. | 181 samples compared to a commercially available immunoassay. Passing & Bablok regression: y = 1.005x - 0.0030, R² = 0.9748. 95% CI for slope: 0.988 to 1.026. 95% CI for intercept: -0.0873 to 0.0411 mIU/L. |
| Reference Range | Establishment of a normal range for healthy individuals. | Established in 130 apparently healthy individuals: 0.357 – 4.789 mIU/L (Median: 1.438 mIU/L). |
| Reproducibility/Precision | Low coefficient of variation (%CV) for within-run and total precision across different concentrations (low, medium, high). Values typically less than 10-15% depending on concentration. | For 6 serum samples and 3 controls, total %CVs ranged from 0.3% to 5.5%. For example, control KC1 (0.6401 mIU/L) had a total %CV of 4.3%, and sample 6 (82.56 mIU/L) had a total %CV of 4.2%. |
| Linearity | Demonstration of a linear response across the measuring range. Typically, R² near 1, slope near 1, and intercept near 0 within the reportable range. | Linear from 0.02 mIU/L to 90 mIU/L. Passing & Bablok regression: y = 0.9807x + 0.0013, R² = 0.9997. |
| Limit of Blank (LoB) | LoB value established. | 0.014 mIU/L |
| Limit of Detection (LoD) | LoD value established. | 0.02 mIU/L |
| Limit of Quantitation (LoQ) | LoQ established, typically at |
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.