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The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

The Access Ostase assay is a one-step sandwich immunoenzymatic assay. The Access Ostase assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access Ostase assay reagent pack, Access Ostase assay calibrators, Access Ostase QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The provided text describes the performance of the Beckman Coulter Access Ostase assay on the Dxl 9000 Access Immunoassay Analyzer, comparing it to the predicate device (Access Ostase on Access 2 Immunoassay System).

Here's an analysis of the acceptance criteria and the studies performed, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a separate, clear table format. However, it does outline the assay's design goals for imprecision and then presents the results. For other parameters like linearity and detection limits, it states the claimed values or that linearity was demonstrated. I will infer the acceptance criteria for imprecision from the "designed to have" statement and present the reported performance.

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

• Method Comparison Test Set:

  • Sample Size: 163
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involved comparing results from two different immunoassay systems (Access 2 and Dxl 9000) using patient samples, implying real-world or simulated clinical samples.

• Imprecision Test Set:

  • Sample Size: 80 for each of the 5 samples tested (total of 400 individual measurements of samples).
  • Data Provenance: Not explicitly stated. The study involved testing "multiple samples in duplicate in 2 runs per day for a minimum of 20 days," which suggests a controlled laboratory setting.

• Linearity, LoB, LoD, LoQ: The sample sizes for these studies are not explicitly mentioned, nor is their specific provenance beyond being performed "on the Dxl 9000 Access Immunoassay Analyzer."

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 an in vitro diagnostic (IVD) assay that measures quantitative analytes like bone alkaline phosphatase. The "ground truth" for such devices is typically established through reference methods, certified reference materials, or statistical comparison to a legally marketed predicate device (as done here). There are no "experts" in the human perception or diagnostic interpretation sense used to establish ground truth for this type of test.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved to establish ground truth. This is a quantitative immunoassay.

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 in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

This device is an automated immunoassay system that provides quantitative results. The performance studies described (Method Comparison, Imprecision, Linearity, LoB/LoD/LoQ) inherently represent the standalone performance of the device (including its reagents and analyzer software) in generating these quantitative results. It operates without direct human-in-the-loop interpretation of the primary measurement signal for the reported value. A human reviews the final numerical result, but the device itself generates that result primarily through an automated process.

7. The type of ground truth used:

• Method Comparison: The ground truth was established by comparison to the predicate device (Access Ostase on Access 2 Immunoassay System). This assumes the predicate device's measurements represent a valid "truth" for substantial equivalence purposes. Patient samples were used, and their values from one system were compared to the other.
• Imprecision: The ground truth for evaluating imprecision is the inherent variability of the measurement process itself, determined by repeated measurements of samples with known (or established) concentrations.
• Linearity, LoB, LoD, LoQ: These are determined using samples of known concentrations (dilutions, blank samples, low-concentration samples) and statistical methods based on CLSI guidelines.

8. The sample size for the training set:

Not applicable. This device is a quantitative immunoassay system, not a machine learning or AI model that requires a "training set" in the conventional sense. The development of such assays involves extensive research, development, and optimization of reagents and protocols, but this is distinct from "training data" for an algorithm.

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.

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Beckman Coulter, Inc's Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

The Access Ostase Assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay System for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma.

{
  "acceptance_criteria_and_device_performance": {
    "title": "Acceptance Criteria and Reported Device Performance for Access® Ostase® Assay",
    "table": {
      "headers": ["Performance Characteristic", "Acceptance Criteria (Implicit via predicate comparison)", "Reported Device Performance"],
      "rows": [
        ["Method Comparison (Slope vs. Predicate)", "Close to 1", "0.9756"],
        ["Method Comparison (Intercept vs. Predicate)", "Close to 0", "-0.5987"],
        ["Method Comparison (Correlation r vs. Predicate)", "Close to 1", "0.9895"],
        ["Mean % Difference (Osteoporosis vs. Predicate)", "Low Percentage Difference", "-5.96%"],
        ["Mean % Difference (Paget's vs. Predicate)", "Low Percentage Difference", "-7.01%"],
        ["Between-Run %CV (Imprecision)", "Low Percentage (e.g.,

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Beckman Coulter's Access Ostase QC is intended for use in monitoring the reliability and overall performance of the Access Ostase Immunoassay system in the clinical laboratory. The use of control materials allow the laboratorian to monitor linearity along with analytical error and imprecision.

The Access Ostase QC are bi-level ready-to-use defined protein-based liquid controls manufactured by Beckman Coulter, Inc. Each kit contains 1 X 4 mL bottles for each level of control.

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those acceptance criteria. It primarily focuses on the submission details, regulatory classification, and intended use of the Access Ostase QC device.

However, based on the general understanding of Quality Control Materials for in vitro diagnostics, I can infer the likely nature of such a study and the potential acceptance criteria, though the specific values are not present in the document.

Here's a breakdown of what can be extracted and what needs to be inferred for a Quality Control Material like "Access Ostase QC":

Inferred Acceptance Criteria and Reported Device Performance (as typically expected for QC materials):

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