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Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For in vitro diagnostic use.

CRPex-HS C-reactive protein LIT assay is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. CRPex-HS C-reactive protein LIT assay is a hs-CRP assay for CRP quantification in the lower range.

Here's a breakdown of the acceptance criteria and study findings for the CRPex-HS C-reactive protein LIT Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, Wako CRP-UL. The primary performance metric presented is correlation.

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

• Sample Size: N = 141 (for the correlation study).
• Data Provenance: Not explicitly stated (e.g., country of origin). Likely retrospective, as it involves comparing results to an existing predicate device using collected samples.

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

Not applicable. This is an in vitro diagnostic (IVD) assay for quantitative measurement. The "ground truth" for the test set is established by the measured values from the predicate device (Wako CRP-UL) and the CRPex-HS assay itself, as well as the known concentrations of calibrators. There are no human experts "establishing ground truth" in the diagnostic interpretation sense for this type of device.

4. Adjudication Method for the Test Set

Not applicable. As described above, the study involves quantitative measurement and comparison to a predicate device, not subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tests that rely on human interpretation to assess reader performance with and without AI assistance. This device is an automated in vitro diagnostic assay.

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

Yes, the study primarily demonstrates standalone performance of the CRPex-HS C-reactive protein LIT assay. It measures the assay's output directly and compares it to a predicate device. "Human-in-the-loop" is relevant for clinical interpretation, but the assay itself, as an IVD, functions as a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth for the correlation study is the quantitative result obtained from the predicate device, Wako CRP-UL. For the assay range and interference studies, the "ground truth" refers to known concentrations of CRP in control samples and known concentrations of interfering substances added to samples. Essentially, it's a reference measurement or established reference material.

8. The Sample Size for the Training Set

Not applicable. This device is a reagent-based assay system, not an AI/machine learning algorithm requiring a "training set" in the conventional sense. The "training" of the device involves the development and optimization of the chemical reagents and protocols, which is an iterative laboratory process, not a data-driven model training.

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

Not applicable, as there is no specific "training set" for an AI algorithm. The development of the assay's performance characteristics (like sensitivity, specificity of the antibodies, reagent concentrations, etc.) is based on standard laboratory practices and experimentation to achieve optimal performance, utilizing calibrated reference materials and internal standards.

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