Search Results

The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The system is for in vitro diagnostic use only.

The chemistry module of the DxC 500i Clinical Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (OC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.

The Access Cortisol assay is a competitive binding immuno-enzymatic assay designed for use on Beckman Coulter's Access immunoassay analyzers in a clinical laboratory setting.

The DxC 500i Clinical Analyzer is an integrated chemistry-immunoassay work cell that combines Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The DxC 500i instrument has a single user interface and common point of entry for sample racks; the sample handling unit operates as a parallel processor and sample manager for both sides of the instrument. The DxC 500i operates in conjunction with the existing reagents, calibrators, controls, and system solutions for the AU and Access instrument families.

The provided text describes the Beckman Coulter Access Cortisol assay on the DxC 500i Clinical Analyzer and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and study information:

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

Ask a specific question about this device

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

Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immuoasay Systems to aid in the diagnosis of myocardial infarction (MI).

The Access hsTnl and the Access 2 Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma.

The Access hsTnI reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnl including:

• R1a: Dynabeads* paramagnetic particles coated with mouse . monoclonal anti-human cTnl antibody suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA).

The provided text describes the Beckman Coulter Access hsTnI diagnostic device, an immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma to aid in the diagnosis of myocardial infarction (MI).

Here's an analysis of the acceptance criteria and study that proves the device meets them:

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

The document provides a comparison of the new device (Access hsTnI) with its predicate device (Access AccuTnI+3 Reagent) and details multiple performance characteristics. The specific acceptance criteria themselves are not explicitly stated as pass/fail thresholds in a dedicated table, but rather implied through the performance data presented and comparison to the predicate. The "Summary of Studies" section details the studies conducted to establish the device's performance, which in effect serves as demonstration of meeting acceptance criteria for analytical and clinical performance.

Implicit Acceptance Criteria and Reported Performance from the Text:

• Overall: 17.5 pg/mL (95% CI: 12.6–20.7 pg/mL)
• Females: 11.6 pg/mL (95% CI: 8.4–18.3 pg/mL)
• Males: 19.8 pg/mL (95% CI: 14.0–42.9 pg/mL)
  Serum:
• Overall: 18.2 pg/mL (95% CI: 13.1–23.1 pg/mL)
• Females: 11.8 pg/mL (95% CI: 8.7–18.7 pg/mL)
• Males: 19.7 pg/mL (95% CI: 14.3–44.3 pg/mL) |
  | Precision | Total CV of ≤8% at >0.075 ng/mL; SD ≤0.006 at ≤0.075 ng/mL | ≤ 10% within-laboratory CV for concentrations ≥ 11.5 pg/mL; ≤ 1.15 pg/mL within-laboratory SD for concentrations ± 2 SD; 10% for > 11.5 pg/mL, 2.30 pg/mL for ≤ 11.5 pg/mL). |
  | Interfering Substances | Not detailed for predicate | No significant interference found for tested compounds at specified concentrations (defined as concentration shift > ± 2 SD; 10% for > 11.5 pg/mL, 2.30 pg/mL for ≤ 11.5 pg/mL). |

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

• 99th percentile URL study:

  • Sample Size: 1089 subjects (595 females, 494 males for lithium heparin plasma; 595 females, 493 males for serum).
  • Provenance: Multicenter prospective study conducted at five geographically diverse locations throughout the United States.

• Clinical performance study:

  • Sample Size: 1,851 evaluable subjects.
  • Provenance: Multicenter prospective study conducted for ED patients presenting with chest pain or equivalent ischemic symptoms suggestive of Acute Coronary Syndromes (ACS). Patients were enrolled from 14 geographically diverse, primary care hospital-associated emergency departments in the United States, reflecting regional, urban, suburban, and rural patient populations.

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

• Ground Truth Experts: An independent panel of expert physicians.
• Qualifications of Experts: Not explicitly stated beyond "expert physicians." However, their role in adjudicating MI statuses using criteria consistent with the Universal Definition of Myocardial Infarction suggests expertise in cardiology and MI diagnosis. They were blinded to assay results and attending physicians' diagnoses.

4. Adjudication method for the test set

• Adjudication Method: "True MI statuses of all subjects were adjudicated by an independent panel of expert physicians using criteria consistent with the Universal Definition of Myocardial Infarction." The specific number of experts involved in the panel (e.g., 2+1, 3+1) is not provided.

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

• This device is a laboratory immunoassay for measuring a biomarker (cardiac troponin I), not an imaging-based AI diagnostic tool requiring "human readers" or "AI assistance." Therefore, an MRMC comparative effectiveness study, in the context described, was not performed and is not applicable.

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

• This is a standalone diagnostic assay (algorithm equivalent in this context), as it directly measures cTnI levels. Its performance (sensitivity, specificity, PPV, NPV) was evaluated without direct human intervention in the result generation or interpretation of the assay itself during the study. The study focuses on the diagnostic accuracy of the assay using the established 99th percentile URLs against an expert-adjudicated ground truth. However, the note explicitly states: "The Access hsTnl assay is not intended to be used in isolation; results should be interpreted in conjunction with other diagnostic tests and clinical information," indicating that clinical decision-making ultimately involves a human interpreting the result in context.

7. The type of ground truth used

• Ground Truth Type: Expert consensus. Specifically, "True MI statuses of all subjects were adjudicated by an independent panel of expert physicians using criteria consistent with the Universal Definition of Myocardial Infarction."

8. The sample size for the training set

• The document describes performance studies and reference range establishment. It does not mention a separate "training set" in the context of machine learning. The studies described are for validation and characterization of the assay and its clinical performance. The 99th percentile URL was established using 1089 healthy subjects, and the clinical performance was evaluated on 1,851 evaluable subjects. These represent the datasets used to demonstrate key performance metrics.

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

• As noted above, the concept of a "training set" in the machine learning sense is not directly applicable here. For the clinical performance evaluation (which is the closest analog to a test set in ML terms for diagnostic accuracy), the ground truth for MI status was established by "an independent panel of expert physicians using criteria consistent with the Universal Definition of Myocardial Infarction."

Ask a specific question about this device