Search Results

The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 Analyzer -- for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute noronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassav is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer,

The provided text is a 510(k) summary for the IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information needed to fill out all requested sections about acceptance criteria, device performance, ground truth establishment, or sample sizes for testing and training.

Therefore, I can only provide limited information based on the text provided.

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of precision, accuracy, or correlation coefficients, nor does it present detailed study results proving the device meets particular thresholds. It asserts substantial equivalence to a predicate device, which inherently means its performance should align with the predicate's established performance for the intended uses. Without specific study data from the document, I cannot create a table of acceptance criteria and reported device performance.

Study Information Based on Provided Text:

Here's what can be inferred or explicitly stated from the given text:

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

   • Acceptance Criteria: Not explicitly stated in the provided document. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds presented in the summary.
   • Reported Device Performance: Not detailed in the provided document. The document describes the device and its intended use but does not present the results of performance studies (e.g., accuracy, precision, linearity).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size for Test Set: Not specified in the provided document.
   • Data Provenance: Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Number of Experts: Not applicable or specified. This device is an in vitro diagnostic (IVD) immunoassay. The "ground truth" for such devices typically refers to a reference method or validated standard, not expert consensus as in imaging studies.
   • Qualifications of Experts: Not applicable or specified.

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

   • Adjudication Method: Not applicable or specified. This is relevant for studies involving human interpretation (e.g., radiology), not typically for automated immunoassay performance evaluation.

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:

   • MRMC Comparative Effectiveness Study: Not applicable. This device is an automated immunoassay for quantitative measurement of C-reactive protein, not an AI-assisted diagnostic tool for human interpretation.

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

   • Standalone Performance: The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is an automated, standalone diagnostic test. Its performance is evaluated intrinsically through analytical studies (e.g., precision, accuracy, linearity) against reference methods, rather than in conjunction with human-in-the-loop scenarios. The summary does not provide details of these studies or their results.

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

   • Type of Ground Truth: For an immunoassay, the "ground truth" for performance studies would typically be established using a reference method, a comparative method deemed accurate, or certified reference materials/calibrators with known concentrations of C-reactive protein. The specific method used is not detailed in this summary.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable or specified. This device is a traditional immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its reagents and calibration curves are developed and optimized through laboratory procedures, not by training on a dataset.

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

   • Ground Truth for Training Set: Not applicable. As explained above, this is not an AI/ML device that uses a training set with established ground truth labels in the typical sense. Reagent and assay development involves standard chemical and biological validation processes.

Ask a specific question about this device