Search Results

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results.

The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Access TSH (3rd IS) assay is a two-site immunoenzymatic ("sandwich") assay. The Access TSH (3rd IS) reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators and wash buffer.

The Dxl 9000 Access Immunoassay Analyzer is a fully automated, continuous, random-access sample processing and analysis instrument. The Dxl 9000 Access Immunoassay Analyzer uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

The provided text describes the performance of the Access TSH (3rd IS) Assay on the DxI 9000 Access Immunoassay Analyzer. This is an in vitro diagnostic device, and the detailed information typically provided for AI/ML devices regarding ground truth establishment, expert qualifications, and MRMC studies is not directly applicable to this type of device.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

• %CV ranged from 2.5% to 4.5%.
  For TSH concentrations ≤ 0.02 µlU/mL:
• SD ranged from 0.0007 to 0.0014.
  (Detailed table with specific sample means and SD/CV values provided in the text) |
  | Reproducibility | SD ≤ 0.0038 for values ≤ 0.02 ulU/mL
  CV 0.02 ulU/mL | For values ≤ 0.02 ulU/mL (Sample 1, mean 0.024): Overall Reproducibility SD = 0.0010 (meets criteria)
  For values > 0.02 ulU/mL:
• Sample 2 (mean 0.37): Reproducibility CV = 4.3% (meets criteria)
• Sample 3 (mean 4.8): Reproducibility CV = 3.7% (meets criteria)
• Sample 5 (mean 12): Reproducibility CV = 3.8% (meets criteria)
• Sample 4 (mean 46): Reproducibility CV = 3.4% (meets criteria) |
  | Linearity | Not explicitly stated as a numerical criterion, but implies demonstration of accuracy across the measuring range. | Linear throughout the analytical measuring interval of approximately 0.01 - 50.0 µIU/mL (mIU/L). |
  | Limit of Blank (LoB)| Not explicitly stated as a numerical criterion, but implies a low detection threshold. | 0.002 µIU/mL |
  | Limit of Detection (LoD)| Not explicitly stated as a numerical criterion, but implies a low detection threshold. | 0.003 µIU/mL |
  | Limit of Quantitation (LoQ)| LoQ must be greater than or equal to LoD. | Maximum LoQ determined was 0.001 µlU/mL, but reported as 0.003 µIU/mL to align with LoD, following CLSI EP17-A2 recommendation. |

2. Sample size used for the test set and the data provenance

• Method Comparison Test Set: 111 serum samples.
• Imprecision Test Set: 80 replicates per sample level across multiple runs/days.
• Reproducibility Test Set: 75 replicates per sample level.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given it's an in vitro diagnostic device, these samples are typically laboratory-generated or clinical samples collected for analytical validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the analytical performance studies conducted for this in vitro diagnostic device. The "ground truth" for these studies is established by the reference method (the predicate device for method comparison) or by known concentrations/spikes for other performance characteristics like linearity, LoB, LoD, LoQ, and imprecision.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies or for subjective interpretations of results, not for the analytical performance of an immunoassay system where quantitative measurements are directly compared.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an automated immunoassay analyzer, not an AI-assisted diagnostic tool that requires human interpretation or aids human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented as "Summary of studies" directly represent the standalone performance of the Access TSH (3rd IS) Assay on the DxI 9000 Access Immunoassay Analyzer. The device is an automated system, and its performance is evaluated directly without human interpretation in the analytical process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Method Comparison: The predicate device, Access TSH (3rd IS) Assay on UniCel DxI 800 Immunoassay System (K153651), served as the reference or "ground truth" for comparative performance.
• Imprecision, Reproducibility, Linearity, LoB, LoD, LoQ: "Ground truth" is established by the study design, using known concentrations, spiked samples, or statistical methods (e.g., CLSI guidelines) to define true values and assess the device's ability to measure them accurately and precisely.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set in the typical sense. Its performance is based on the inherent analytical characteristics of the reagents and instrumentation.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

Ask a specific question about this device