Search Results

For in vitro diagnostic use only. Rx Only.

VITROS Chemistry Products hsCRP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.

The quantitative measurement of C-reactive protein (CRP) is performed using the VITROS Chemistry Products hsCRP Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products FS Calibrator 1 on the VITROS 5,1 FS/4600 Chemistry System and the VITROS 5600 Integrated System. The VITROS Chemistry Products hsCRP Reagent is a dual chambered package containing ready-to-use liquid reagents. Samples, calibrators and controls are mixed with Reagent 1 containing a buffer. Addition of anti-CRP antibodies coupled to latex microparticles (Reagent 2) produces an immunochemical reaction yielding CRP antigen/antibody complexes. The turbidity is measured spectrophotometrically at 660 nm. Once a calibration has been performed for each reagent lot, the CRP concentration in each unknown sample can be determined using the stored calibration curve and the measured absorbance obtained in the assay of the sample.

The provided document describes the K160712 510(k) submission for the VITROS Chemistry Products hsCRP Reagent. This is an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, the information regarding acceptance criteria and study design (especially related to human readers, ground truth establishment, and test set/training set specifics) is described through the lens of an IVD device, focusing on analytical performance rather than diagnostic accuracy based on images or clinical data interpreted by AI.

Here's a breakdown of the information provided, tailored to the context of an IVD device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison Test Set Sample Size: 119 human serum samples were tested. Of these, 113 were within the measuring range of both the VITROS hsCRP assay and the predicate Diazyme hsCRP assay.
• Data Provenance: The document does not explicitly state the country of origin. It refers to "human serum samples" and "human serum sample pools." Given the FDA submission, it is likely the data was generated in the US or at sites compliant with US regulatory standards. The study was retrospective in nature as it involved testing collected samples.
• Precision Study Sample Size: Three human serum sample pools were used, tested in five replicates, once per day for five days.

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

For this IVD device, the "ground truth" for the test set is established by the results from the predicate device (Diazyme hsCRP assay on Hitachi 917 Systems) for method comparison, and by traceability to internationally recognized reference materials (ERM®-DA474/IFCC, ERM®-DA472/IFCC) for analytical performance characteristics.

There are no "experts" in the traditional sense (e.g., radiologists interpreting images) involved in establishing ground truth for analytical performance of an IVD reagent in this context. The truth is defined by the established analytical methods and reference standards.

4. Adjudication Method for the Test Set

Not applicable in the context of an IVD analytical performance study. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in image-based diagnostic studies where human interpretation is the primary source of truth or where disagreement among experts needs resolution.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

Not applicable. This is an analytical performance study for an in vitro diagnostic reagent, not a cognitive AI/ML device assisting human readers with clinical decision-making. No human readers are involved in the "interpretation" of the analytical results in a comparative effectiveness study design typically seen for AI devices.

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

The entire performance study for this IVD device is "standalone" in the sense that it evaluates the performance of the reagent and instrument system itself, independent of human interpretive bias. The measurements are quantitative chemical analyses performed by automated systems.

7. The Type of Ground Truth Used

• Method Comparison: Ground truth for comparison was the measurement result from the legally marketed predicate device (Diazyme hsCRP assay).
• Precision, Linearity, Detection Limits: Ground truth is linked to international reference materials (ERM®-DA474/IFCC, ERM®-DA472/IFCC) and established analytical chemistry principles and CLSI guidelines which dictate how these performance characteristics are defined and measured. The concept here is analytical accuracy and precision against known values or standards, rather than a diagnostic 'truth' about a patient's condition.
• Reference Range: Established against a healthy population, consistent with CLSI EP28-A3 guidelines.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an IVD reagent, not an AI/ML algorithm that requires a "training set." The reagent and instrument system are developed and optimized through standard chemical and engineering processes, not through machine learning on a data set.

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

Not applicable, as there is no "training set" in the context of this IVD reagent's development as described in the document.

Ask a specific question about this device