(165 days)
The CRP-Latex (II) SEIKEN High Sensitivity Assay kit is a quantitative assay for use with an Automated Chemical Analyzer for the determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury, and inflammatory disorders.
The CRP-Latex (II) SEIKEN High Sensitivity Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein in human serum. Antigen in the sample bonds to the specific anti-CRP antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on an automated analyzer (the Hitachi 717 was used for these studies), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.
Here's a breakdown of the acceptance criteria and study information for the DENKA SEIKEN CO.,LTD. CRP-Latex (II) SEIKEN High Sensitivity Assay Kit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with Predicate Device (Donor Samples) | r = 0.999 (Correlation Coefficient) |
| Slope (Least Squares) | 1.034 |
| Intercept (Least Squares) | -0.173 |
| Slope (Passing/Bablock) | 1.014 |
| Intercept (Passing/Bablock) | -0.094 |
| Correlation with Predicate Device (Normal Adult Donor Samples) | r = 0.996 (Correlation Coefficient) |
| Precision (Within Run & Between Day) | |
| Level 1 (% CV) | Did not exceed 1.81% |
| Level 2 (% CV) | Did not exceed 1.65% |
| Level 3 (% CV) | Did not exceed 1.3% |
| Lower Level of Detection (Sensitivity) | 0.05 mg/L |
| Assay Range | Up to 10.0 mg/L |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- 70 donor samples for comparative performance studies against the predicate device.
- 388 normal adult donor samples for supportive clinical data.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It refers to "donor samples" and "normal adult donor samples," suggesting a clinical setting for sample collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. The study compares the new device against a legally marketed predicate device, using the predicate device's results as the reference for comparison.
4. Adjudication Method for the Test Set
Not applicable. The study involved a direct comparison of a new device's readings with a predicate device's readings, rather than an expert review process requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study is focused on the analytical performance of an in vitro diagnostic assay, comparing its results to a predicate device, not on the impact of human readers with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's analytical performance (precision, sensitivity, assay range) was evaluated independently. However, the primary "standalone" output as commonly understood for AI/CAD devices (algorithm-only performance) is not directly applicable here. The device itself is an assay, and its performance is measured by its output values. The comparison with the predicate device also represents a form of standalone performance evaluation in relation to an established method.
7. Type of Ground Truth Used
The "ground truth" for the comparative performance study was established by the results obtained from the legally marketed predicate device (N High Sensitivity CRP Assay [Dade Behring Inc.]). For analytical performance metrics like precision, the "ground truth" would be derived from the inherent analytical properties of the assay and control materials.
8. Sample Size for the Training Set
Not applicable. This is an in-vitro diagnostic assay based on immunological principles, not an AI/machine learning device that requires a training set in the conventional sense. The device's mechanism is based on antigen-antibody reactions, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/machine learning algorithm for this device.
§ 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).