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Reagents: For the quantitative measurement of C-Reactive Protein (CRP) concentration in serum or plasma. For In Vitro Diagnostic Use. Calibrator: For the calibration of the N-geneousTM Wide Range CRP assay. For In Vitro Diagnostic Use.

The Genzyme N-geneous™ Wide Range CRP Reagent is a two-reagent method for the quantitative measurement of CRP concentration from 0.04 to 320 mg/L in serum or plasma. The test is an enhanced latex-agglutination turbidimetric immunoassay. Sample is added to a buffer solution and mixed with a suspension of mouse anti-human CRP monoclonal antibody, which is bound to latex. CRP binds to the latex-bound antibody, which agglutinates. The light scattering caused by the increase in particle size is used as a measure of CRP concentration. The amount of light scattering is proportional to the concentration of CRP in the sample. N-geneous™ Wide Range CRP Calibrator Set is a stabilized human serum designed to be used to calibrate the N-geneous™ Wide Range CRP Reagent and is sold separately.

Here's an analysis of the provided text regarding the N-geneous™ Wide Range CRP Reagent Kit, structured to answer your questions:

Acceptance Criteria and Device Performance Study for N-geneous™ Wide Range CRP Reagent Kit

The 510(k) submission for the N-geneous™ Wide Range CRP Reagent Kit demonstrates substantial equivalence to a predicate device, the Dade Behring N High Sensitive CRP method, primarily through comparative performance and precision studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for the comparative performance and precision studies in terms of pre-defined thresholds. Instead, it presents the results of these studies and concludes that the device's performance is "substantially equivalent" or "acceptable."

However, we can infer the implicit performance targets based on the evaluation presented. For devices seeking substantial equivalence, a high correlation with a legally marketed predicate device and acceptable precision (low variability) are key.

2. Sample Size and Data Provenance

• Sample Size for Test Set (Comparative Performance): 229 serum samples.
• Data Provenance: The document does not explicitly state the country of origin. It describes "comparative performance studies" and "precision studies" conducted on the Hitachi 912 clinical analyzer. Given Genzyme Diagnostics is located in Cambridge, MA, it's reasonable to infer the studies were likely conducted in the US, but this is not explicitly stated. The studies used "serum samples" and "sera that were stored frozen (-20°C) and thawed prior to use." This indicates the data is retrospective in the sense that the samples were collected prior to the full study, but they are prospectively analyzed in the context of this study.

3. Number of Experts and Qualifications for Ground Truth

• This document describes a diagnostic device (reagent and calibrator) for quantitative measurement of CRP. The "ground truth" for the comparative performance study is the measurement obtained from the predicate device, the Dade Behring N High Sensitive CRP method.
• No human experts were used to establish ground truth in the sense of a subjective interpretation or diagnosis. The ground truth is established by the measurement value from the predicate device.

4. Adjudication Method for the Test Set

• Since the "ground truth" is derived from the quantitative measurement of a predicate device, there was no adjudication method involving human experts for the test set.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic devices or tests where human interpretation is involved (e.g., radiology, pathology). This submission is for an in vitro diagnostic reagent and calibrator kit, where the output is a quantitative measure of CRP.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The precision studies (within-run and total precision) directly assess the performance of the N-geneous™ Wide Range CRP Reagent Kit in isolation, without direct comparison to human interpretation or a human-in-the-loop scenario. The comparative performance study also evaluates the algorithm's (reagent's) output against the predicate device's output, essentially a standalone comparison to another device.

7. Type of Ground Truth Used

• The ground truth used for the comparative performance study was the quantitative measurement value obtained from the legally marketed predicate device (Dade Behring N High Sensitive CRP method).
• For the precision studies, the "ground truth" is inherent to the intrinsic variability of the device itself when measuring known concentrations, and the results are reported as mean, standard deviation, and %CV.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. This is common for in vitro diagnostic device submissions where the 'algorithm' is essentially the chemical reaction and light scattering measurement, and the parameters (e.g., reagent concentrations) are established during product development, not typically through a distinct machine learning "training phase" on a separate dataset in the same way an AI/ML diagnostic would. The comparative and precision studies are validation studies, not training studies.

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

• As no explicit training set is described for an AI/ML algorithm, the concept of establishing ground truth for a training set in this context is not applicable. The underlying chemical and physical principles of the immunoassay, along with established laboratory practices and quality control, govern the development and calibration of such a device. The calibrator itself is traceable to CRM470, which serves as a widely accepted "ground truth" or reference material for CRP measurements.

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