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The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma.

The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum or plasma. In the proposed product polystyrene particles coated with mouse monoclonal antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.

Here's an analysis of the provided text regarding the Behring N Latex CRP mono Reagent, focusing on the acceptance criteria and the study proving it, with a strong emphasis on the requested information.

The provided document, a 510(k) Notification, is a regulatory submission for a diagnostic device. It primarily discusses the equivalence to a previously cleared device and the performance characteristics for that purpose. It does not contain information about "acceptance criteria" as would be established for a new clinical study with a predefined performance threshold for clinical use. Instead, it demonstrates performance in terms of correlation with an existing, cleared device for regulatory equivalence.

Therefore, many of the requested categories (like number of experts, adjudication method, MRMC studies, standalone performance with predefined acceptance criteria, and ground truth for a training set) are not applicable or detailed in this type of regulatory document.

Here's the breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document focuses on demonstrating correlation for equivalence rather than predefined clinical acceptance criteria. The "acceptance criteria" here are implicitly satisfactory correlation coefficients, y-intercepts, and slopes relative to a legally marketed device using a different sample type (plasma vs. serum).

Explanation: The document describes "comparative serum versus plasma studies." The "acceptance criteria" are implied by the values themselves – very high correlation coefficients (close to 1), slopes close to 1, and y-intercepts close to 0 indicate excellent agreement between the measurements in serum and plasma, demonstrating that the device performs similarly whether using serum or plasma.

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "Results of comparative serum versus plasma studies," but the number of individual samples (patients or measurements) used for these studies is not given.
• Data Provenance: Not explicitly stated. Given the manufacturer (Behringwerke AG, Marburg Germany) and distributor (Behring Diagnostics Inc., Westwood, MA), the studies were likely conducted either in Germany or the US, or both. The text does not specify if the data was retrospective or prospective.

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

• Not Applicable. This study is a method comparison/correlation study comparing the device's performance with two different sample types (serum vs. plasma). It doesn't involve subjective interpretation by experts to establish a "ground truth" in the way, for example, a diagnostic imaging study would. The quantitative CRP measurements themselves are the output.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

• No. This is a quantitative diagnostic reagent. MRMC studies are typically for imaging or other subjective interpretation tasks where multiple human readers are involved. This device measures a biomarker (CRP concentration).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Partially Applicable / Standalone by Nature: This device, the "Behring N Latex CRP mono Reagent," used with the "Behring Nephelometer Systems," is inherently a standalone quantitative diagnostic test. It provides a numerical output (CRP concentration) based on the biochemical reaction and nephelometry. There isn't an "algorithm only" vs. "human-in-the-loop" distinction in the same way as with AI image analysis. The performance described (correlation coefficients, slopes, intercepts) directly reflects the standalone analytical performance of the reagent and system.

7. The Type of Ground Truth Used

• Comparative Reference Measurement: The "ground truth" for these studies is the measurement of CRP in serum samples using the exact same reagent and system (N Latex CRP mono Reagent K962523, cleared for serum use). The study's purpose is to show that using plasma samples with the proposed device (which is essentially the same device but with an expanded indication for plasma) yields equivalent results to the established serum method. So, it's a comparison to an established, identical measuring system rather than a "ground truth" established by an independent, more definitive method (like pathology for cancer, or outcome data).

8. The Sample Size for the Training Set

• Not applicable / Not explicitly mentioned. This document describes performance for equivalence to an existing device and expanded sample type. There is no mention of a "training set" in the context of machine learning, as this is a biochemical assay. The development of such assays involves extensive R&D and optimization, but the term "training set" is not relevant here.

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

• Not applicable. See point 8. This refers to a chemical/biological assay for an existing biomarker, not an AI or machine learning algorithm requiring a "training set" with ground truth in the conventional sense. The "ground truth" for developing such a reagent would be accurate chemical standards and purified CRP to calibrate the assay.

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The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum.

The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative defermination of C-reactive protein in human serum.

In the proposed product polystyrene particles coated with mouse monoclonal Y antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.

The provided text describes a 510(k) summary for the N Latex CRP mono Reagent, an in vitro diagnostic device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds for correlation or precision that the device needed to meet. Instead, it reports the performance characteristics observed in studies. The legal standard for 510(k) is "substantial equivalence" to a legally marketed predicate device, rather than meeting specific performance criteria.

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

• Sample Size for Test Set: 71 serum samples were used for the correlation study. The precision studies used samples with various CRP concentrations, tested 20 times for intra-assay and 10 times for inter-assay precision.
• Data Provenance: Not specified. The document does not indicate the country of origin of the samples or whether the data was retrospective or prospective.

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

This information is not applicable as the device is an in vitro diagnostic reagent measuring C-reactive protein (CRP) levels. Ground truth is established by the measurement itself, not by expert interpretation of images or clinical assessments in the way it would be for a diagnostic imaging AI. The "ground truth" for the correlation study would implicitly be the results obtained by the predicate device (N Latex CRP).

4. Adjudication Method for the Test Set

This information is not applicable for this type of in vitro diagnostic device, as there's no interpretation by multiple readers requiring adjudication.

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

This information is not applicable as the device is an in vitro diagnostic reagent, not an AI for image analysis or clinical decision support that would involve human readers.

6. Standalone (Algorithm Only) Performance Study

The reported performance characteristics (correlation and precision) are essentially standalone performance evaluations of the N Latex CRP mono Reagent itself, compared to a predicate device or against itself under various conditions. There is no human-in-the-loop component for the measurement of CRP by this device.

7. Type of Ground Truth Used

For the correlation study, the "ground truth" was implicitly established by the measurements obtained using the legally marketed predicate device, N Latex CRP. For precision studies, the measurements themselves define the performance.

8. Sample Size for the Training Set

This information is not applicable. This device is a reagent for a specific biochemical measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the device is inherent in its chemical formulation and calibration process.

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

This information is not applicable for the reasons stated in point 8. The device's calibration refers to a "lot independent standard" rather than a training set with established ground truth.

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