(102 days)
The CRP-Latex (II)X2 SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.
The CRP-Latex (II)X2 SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. 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 chemistry analyzer (the Hitachi 917 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 the study details for the CRP-Latex (II)X2 SEIKEN Assay Kit, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study to Demonstrate Performance |
|---|---|---|---|
| Comparative Performance | High correlation coefficient with predicate device. | r = 0.999 (Least squares) | Comparative performance study on 451 donor samples |
| Slope (Least squares) approaching 1.0. | Slope = 1.012 (Least squares) | Comparative performance study on 451 donor samples | |
| Y-intercept (Least squares) approaching 0.0. | Y-intercept = 0.005 (Least squares) | Comparative performance study on 451 donor samples | |
| Slope (Passing/Bablock) approaching 1.0. | Slope = 1.053 (Passing/Bablock) | Comparative performance study on 451 donor samples | |
| Y-intercept (Passing/Bablock) approaching 0.0. | Y-intercept = -0.004 (Passing/Bablock) | Comparative performance study on 451 donor samples | |
| Precision (Within Run) | % CV for Level 1 not exceeding 7.0%. | % CV for Level 1 did not exceed 7.0% | Precision studies using three levels of control material |
| % CV for Level 2 not exceeding 3.4%. | % CV for Level 2 did not exceed 3.4% | Precision studies using three levels of control material | |
| % CV for Level 3 not exceeding 1.3%. | % CV for Level 3 did not exceed 1.3% | Precision studies using three levels of control material | |
| Precision (Between Day) | % CV for Level 1 not exceeding 7.0%. | % CV for Level 1 did not exceed 7.0% | Precision studies using three levels of control material |
| % CV for Level 2 not exceeding 3.4%. | % CV for Level 2 did not exceed 3.4% | Precision studies using three levels of control material | |
| % CV for Level 3 not exceeding 1.3%. | % CV for Level 3 did not exceed 1.3% | Precision studies using three levels of control material |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: 451 donor samples were used for the comparative performance studies.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective.
-
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 given text. The "ground truth" for the comparative study was the measurement given by the predicate device (N High Sensitivity CRP Assay).
-
Adjudication method for the test set:
- This information is not applicable as the "ground truth" was established by a predicate device's measurements, not by human expert assessment requiring adjudication.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic immunoassay, not an AI-powered diagnostic imaging tool that would typically involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance reported is a standalone (algorithm only) performance, comparing the output of the CRP-Latex (II)X2 SEIKEN Assay Kit to a legally marketed predicate device. The device itself is an automated immunoassay, not one that typically involves a human-in-the-loop for its basic measurement function.
-
The type of ground truth used:
- The "ground truth" for the comparative performance study was the measurements obtained from the legally marketed predicate device, the N High Sensitivity CRP Assay (Dade Behring Inc.).
-
The sample size for the training set:
- This information is not provided in the text. The study describes performance testing against a predicate device, not the development or training of an algorithm that would typically require a separate training set.
-
How the ground truth for the training set was established:
- This information is not provided as a separate training set and its ground truth establishment are not discussed in the context of this 510(k) submission.
§ 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).