Search Results

The Revised C-Reactive Protein Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for the Revised C-Reactive Protein (RCRP) method.

The Dimension® Revised C-Reactive Protein Calibrator is a liquid product. Level 1 contains bovine serum albumin. Levels 2-5 contain human serum base product with added human C-Reactive Protein. The kit consists of ten vials; two at each of five levels.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical or performance study for a diagnostic device.

The document is a 510(k) summary for a calibrator device, not a diagnostic test kit that measures patient analytes directly. For calibrators, the primary focus for substantial equivalence is its intended use, composition, and its ability to properly calibrate the associated analytical system. The "performance" of a calibrator is typically demonstrated through its ability to provide accurate and reproducible calibration curves for the method it's designed to calibrate, rather than through sensitivity, specificity, or predictive values against a ground truth for a disease state.

Here's an attempt to answer your questions based on the limited information provided for this specific type of device submission:

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

Based on the provided document, the "acceptance criteria" for a calibrator device are primarily related to its intended use, composition, and ability to serve its purpose as a calibrator compared to a predicate device. There are no quantitative performance metrics (like accuracy, sensitivity, specificity) typically associated with diagnostic tests.

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

Not applicable in the context of a calibrator device's 510(k) submission. There is no "test set" of patient samples in the way a diagnostic device would have for performance evaluation. The substantial equivalence is based on comparison of specifications and intended use.

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

Not applicable. There is no concept of "ground truth" established by experts for a calibrator itself. The ground truth for the analyte's concentration (C-Reactive Protein) is established by the primary reference standard (IFCC CRM 470) to which the calibrator is traceable.

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

Not applicable. No test set requiring adjudication is mentioned.

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 is a calibrator, not a device involving human readers or AI assistance.

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

Not applicable. This is a calibrator, not an algorithm.

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

The "ground truth" for the concentration of C-Reactive Protein within the calibrator is established by its traceability to a primary standard, specifically IFCC CRM 470. This is a certified reference material, which serves as the highest-level ground truth for the concentration of the analyte.

8. The sample size for the training set

Not applicable. A calibrator device does not involve a training set as would a machine learning algorithm. Its values are determined during manufacturing and validated for consistency and traceability.

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

Not applicable. There is no training set mentioned for this device. The ground truth for the calibrator's analyte concentration is established by traceability to the IFCC CRM 470 primary standard.

Ask a specific question about this device