(61 days)
Good Biotech Corp. CRPex-BR 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 aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use.
Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples.
For In Vitro Diagnostic Use.
CRPex-BR C-reactive protein LIT Kit 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.
This document describes the CRPex-BR C-reactive protein LIT assay, a device for the quantitative determination of C-reactive protein in serum. The submission aims to demonstrate its substantial equivalence to the predicate device, K-ASSAY CRP (1).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format. However, substantial equivalence is claimed based on a correlation study comparing the CRPex-BR C-reactive protein LIT kit with the predicate device, K-ASSAY CRP (1). The performance is reported as a regression analysis and correlation coefficient:
| Performance Metric | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (CRPex-BR C-reactive protein LIT kit vs. K-ASSAY CRP (1)) |
|---|---|---|
| Linear Regression | Not explicitly defined, but close to y=x | y = 0.976 x + 1.179 mg/L |
| Correlation (R²) | Not explicitly defined, but very high (close to 1) | R² = 0.998 |
Additional characteristics for substantial equivalence were presented, indicating the CRPex-BR device aims to match the predicate device in aspects such as intended use, methodology, test objective, test principle, type of test, specimen type, operating requirement, calibrator, sample volume, reagent volume, wavelength selection, and assay range. The interference results are also presented for comparison.
2. Sample size used for the test set and the data provenance
- Sample size for the test set: N = 94
- Data provenance: The document does not specify the country of origin of the data. It's also not explicitly stated whether the study was retrospective or prospective, but given it's a correlation study with patient samples, it's likely retrospective or a cross-sectional prospective study comparing results from the two devices on collected samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" is typically established by comparative measurement to a gold standard or a well-established predicate device, rather than expert review of images or clinical cases. The predicate device (K-ASSAY CRP (1)) served as the reference for comparison, and its measurements were presumably used as the 'truth' for evaluating the new device.
4. Adjudication method for the test set
This information is not applicable/not provided for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or clinical outcomes, where human experts might disagree. For an assay comparing quantitative measurements, the comparison is directly between the numerical results of the two devices.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable to this submission. MRMC studies are relevant for medical imaging AI devices where human readers interpret cases with and without AI assistance. This device is an in vitro diagnostic assay for C-reactive protein measurement, not an imaging interpretation tool. There is no human-in-the-loop interpretation intended for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is fundamentally applicable to this device, though the wording "algorithm only" is more typical for AI software. This device is an automated in vitro diagnostic assay. Its performance, as reported by the y = 0.976 x + 1.179 mg/L and R² = 0.998 correlation with the predicate device, represents its "standalone" performance. There is no human interpretation or intervention in the measurement process of the CRPex-BR assay itself, beyond operating the instrument and preparing samples.
7. The type of ground truth used
The ground truth for evaluating the CRPex-BR device was established by comparison to the results obtained from the predicate device, K-ASSAY CRP (1). This is a common method for demonstrating substantial equivalence for in vitro diagnostic devices, where the predicate is considered the established method.
8. The sample size for the training set
This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic assays like this. "Training set" is a concept primarily used in machine learning or AI where an algorithm learns from data. This device relies on chemical and immunoturbidimetric principles, not machine learning, so there is no "training set" in the AI sense.
9. How the ground truth for the training set was established
As there is no "training set" in the AI sense for this device, this question is not applicable.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).