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The Dade Behring N High Sensitivity CRP assay is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum as well as heparin- and EDTA-plasma by means of particle-enhanced immunonephelometry using Dade Behring Nephelometer Systems. In acute phase response, increased levels of a number of plasma proteins, including Creactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.

N High Sensitivity CRP is a nephelometric assay for the quantitative measurement of C-reactive protein in human serum, or heparinized or EDTA plasma.

This document is a 510(k) summary for the Dade Behring N High Sensitivity CRP assay, a nephelometric assay for the quantitative measurement of C-reactive protein (CRP). The submission is for a modification in the intended use of the device, changing it to "for the detection and evaluation of tissue injury, inflammatory disorders, and associated diseases." The core assay reagents and test system remain unchanged from the previously cleared device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed device performance metrics in the format of a table. It states that the device was previously cleared for a similar intended use ("detection and evaluation of inflammatory disorders, tissue injury and infection") and that the current submission only involves a modification to the intended use.

The justification for the modified intended use is: "This labeling change is supported by a large, published literature base that uses both the Dade Behring methodology as well as other high sensitivity CRP methods." This implies that the device's performance characteristics (accuracy, precision, linearity, etc.) were already established and accepted under the previous 510(k) clearance, and the new intended use is supported by existing clinical evidence of CRP's utility in the expanded conditions.

Therefore, for this specific submission, the "acceptance criteria" appear to be:

• The absence of changes to the assay reagents or test system.
• The existence of a "large, published literature base" supporting the broader clinical utility of high sensitivity CRP methods, including the Dade Behring methodology, for the expanded indications.

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

The document does not describe a new study with a specific test set, sample size, or data provenance. The submission is a labeling change supported by existing literature rather than new clinical trials.

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

Not applicable. As no new test set or ground truth establishment is described in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No new test set or adjudication process is described.

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

No. This is for an in-vitro diagnostic assay (CRP measurement), not an imaging or diagnostic device requiring human reader interpretation in the context of an MRMC study.

6. If a Standalone Performance Study Was Done

The device is an in vitro diagnostic assay. Its performance (accuracy, precision, analytical sensitivity, specificity, etc.) would have been established in previous 510(k) submissions, as it is stated that "FDA has previously cleared this assay via the 510(k) process for the intended use for 'the detection and evaluation of inflammatory disorders, tissue injury and infection'." The current submission explicitly states, "There are no other changes to the assay reagents or test system." Therefore, the standalone (algorithm only) analytical performance would have been established and accepted under the prior clearance. This document does not present new standalone performance data.

7. The Type of Ground Truth Used

For the initial clearance of the assay, the ground truth for CRP measurement would have likely been established through:

• Reference methods: Comparison to a gold standard or well-established CRP measurement method.
• Clinical correlation: Correlation with clinical diagnoses of inflammation, infection, or tissue injury, likely using a combination of clinical assessment, other laboratory markers, and patient outcomes.

However, for this specific submission, which is a modification of intended use, the "ground truth" for supporting the expanded indications ("associated diseases") is based on a "large, published literature base" demonstrating the clinical utility of CRP in these conditions. This is essentially literature-based evidence supporting the clinical relevance of the analyte output.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device that requires a training set in the typical sense. The "training" for the assay's performance characteristics would be the analytical validation studies conducted for its initial clearance, but no specific sample sizes for such studies are provided in this summary.

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

Not applicable, as above. For the initial analytical validation, ground truth would have been established through methods like those described in point 7.

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