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The Diazyme high sensitivity C-reactive protein (hsCRP) assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only.

The Diazyme hsCRP assay calibrator set is intended for use in the calibration of the C-reactive protein (CRP) assay. For in vitro diagnostic use only.

The Diazyme hsCRP assay control set is intended for use as quality controls for the Diazyme hsCRP assay. For in vitro diagnostic use only.

Diazyme hsCRP assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP which has been sensitized to latex particles, agglutination results. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.

Diazyme hsCRP Assay calibrator set is intended for use with the Diazyme hsCRP Assay kit. Five calibration levels are needed for each run. Calibrators are treated exactly the same as patient samples.

Diazyme hsCRP Assay 3-point control set is intended for use with the Diazyme hsCRP Assay kit. Controls are treated exactly the same as patient samples. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly.

Here's a breakdown of the acceptance criteria and study information for the Diazyme hsCRP Assay Kit, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are not explicitly stated in a quantitative manner (e.g., "correlation coefficient must be ≥ 0.95"). Instead, the submission demonstrates substantial equivalence to the predicate device by showing comparable performance metrics. The reported device performance serves as the evidence that these implicit "acceptance criteria" (i.e., being substantially equivalent to the predicate) have been met.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This device is a diagnostic assay, and as such, the studies described are clinical analytical performance studies, not typically involving human reader assessment (like an MRMC study) or needing a ground truth established by experts for imaging.

2. Sample Size Used for the Test Set and Data Provenance

• Accuracy/Method Comparison Study:
  • Sample Size: 57 human serum samples
  • Data Provenance: Not explicitly stated, but originating from human serum samples. The study compared the new device against a predicate method, suggesting samples were collected for this purpose (likely prospective or from a banked collection). No country of origin is mentioned.
• Precision Study:
  • Sample Size:
    • 3 levels of serum-based controls: 80 measurements each (2 runs/day x duplicates x 20 days)
    • 1 serum sample (approx. 3.6 mg/L CRP): 80 measurements (2 runs/day x duplicates x 20 days)
    • 1 serum sample (approx. 15.6 mg/L CRP): 20 measurements (2 runs/day x duplicates x 5 days)
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared controls and collected serum samples. No country of origin is mentioned.
• Interference Study:
  • Sample Size: Not specified for the number of interfered samples, but for each interfering substance, the effect was evaluated at specific concentrations.
  • Data Provenance: Not specified, but likely laboratory-prepared samples with added interferents.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is an in vitro diagnostic assay; the "ground truth" for the test set in the accuracy study was established by the predicate device's measurement of CRP concentrations in the same samples. The precision study used controls with known, established CRP concentrations, and serum samples which had their CRP levels determined by the device itself via repeated measurements.

4. Adjudication Method for the Test Set

N/A. Not applicable for this type of in vitro diagnostic assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this in vitro diagnostic assay, which directly measures an analyte concentration rather than requiring human interpretation of clinical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the "standalone" performance is what these analytical studies evaluate. The Diazyme hsCRP Assay is an automated system for quantitative determination of CRP without direct human interpretation of results in the way an imaging AI algorithm would be. The precision, accuracy, and interference studies demonstrate the standalone performance of the assay kit.

7. The Type of Ground Truth Used

• Accuracy/Method Comparison Study: The ground truth was established by the predicate device (Roche Tina-Quant hsCRP assay) measuring CRP concentrations in the same human serum samples.
• Precision Study: The ground truth for the control samples was their known, established CRP concentrations. For the serum samples, their "true" value was effectively taken as the mean of the numerous repeated measurements.
• Interference Study: The ground truth was the expected CRP concentration in samples without interferents, to determine the deviation caused by the interfering substances.

8. The Sample Size for the Training Set

N/A. This device is an immunoturbidimetric assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical detection.

9. How the Ground Truth for the Training Set Was Established

N/A. As stated above, this device does not use a training set in the AI/ML context.

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Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.

Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay systems within the clinical range.

The provided text describes the 510(k) summary for Good Biotech Corp.'s CRPex CRP Controls, intended for use as an assayed quality control material for serum C-reactive protein (CRP) analysis. It focuses on demonstrating substantial equivalence to a predicate device, Roche CRP T Control N.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are primarily demonstrating substantial equivalence to a predicate device by showing comparable characteristics. The "performance" is implicitly the C-reactive protein concentration range.

Note: While the exact "acceptance criteria" for the concentration ranges aren't explicitly stated as numerical targets that were met, the submission implies that these ranges are deemed acceptable for the intended use and demonstrate equivalence to the predicate control.

2. Sample Sizes Used for the Test Set and Data Provenance

This document does not provide information on sample sizes used for a test set or data provenance for performance studies. As a quality control material, the "study" typically involves determining the assigned values and stability of the control, rather than a diagnostic performance study on patient samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For a quality control material, "ground truth" would typically refer to the accurately assigned values of CRP within the control, established through rigorous analytical methods and reference materials, rather than expert consensus on diagnostic images or clinical data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which are not applicable to the evaluation of a quality control material.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This document does not mention an MRMC comparative effectiveness study. MRMC studies are typically conducted for diagnostic devices (e.g., imaging AI) where human readers interpret cases with and without AI assistance. This is not applicable to a CRP control material.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable to the given device. The CRPex CRP Controls are a material used to assess the performance of other assay systems, not a standalone diagnostic algorithm. The "performance" of the controls themselves relates to their stability, homogeneity, and accurately assigned values, which are evaluated through analytical methods.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" refers to the assigned C-reactive protein concentrations within the various control levels (L, M, H). This would be established through:

• Quantitative analytical methods: Using a reference method or a highly accurate clinical analyzer calibrated against certified reference materials.
• Traceability to international standards: Ensuring the assigned values are traceable to recognized CRP standards.

The document states that the controls have "assigned C-reactive protein concentration," indicating this type of ground truth was established.

8. Sample Size for the Training Set

This information is not provided. As a quality control material, there isn't a "training set" in the context of machine learning or AI. The development of the control involves formulation, testing for stability, homogeneity, and value assignment, not training an algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" in the context of this device. The ground truth (assigned CRP concentrations) for the control material itself would be established through analytical testing and value assignment protocols, as described in point 7.

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