(165 days)
A C-reactive protein immunological test system us a device that consists of the reagents used to measure by immunologiyal techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protcin aids in evaluation of the amount of injury to body tissucs.
The Wako CRP Calibrator and Wako CRP Calibrator Sct are designed to be used with the Wako CRP test for the determination of the C-Reactive protein in serum.
The Wako CRP test is an in vitro assay for the quantitative determination of C-reactive protein in serum. When a sample is mixed with Buffer and Antibody, CRP in the sample combines specifically with anti-human CRP antibody (goat) in the Antibody to yield an insoluble aggregate that causes increased turbidity in the solution. The degree of turbidity of solution can be measured optically and is proportional to the concentration of CRP in the patient's sample.
The provided text is a 510(k) summary for the Wako CRP test, an in vitro assay for the quantitative determination of C-reactive protein in serum. It describes the intended use, principle of the method, and general performance characteristics like linearity and minimum detectable level. However, it does not explicitly provide a formal table of acceptance criteria or a detailed study section with specific data proving the device meets those criteria.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document hints at performance specifications but doesn't present them as formal acceptance criteria with corresponding study results in a table format.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Linearity (one-point calibration) | Linear up to 150 mg/L |
| Linearity (multi-point calibration) | Linear up to >250 mg/L (highest calibrator) Note: The text states "more than 250 mg/L," but later says "230 mg/L when using the Wako CRP Calibrator Set." This creates a slight ambiguity. |
| Linearity (single-point calibrator) | Linear to 200 mg/L |
| Minimum Detectable Level | Estimated to be 1 mg/L |
| Precision | Acceptable values can be obtained on a day-to-day basis |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test sets or the provenance (e.g., country of origin, retrospective/prospective) of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The Wako CRP test is an in vitro diagnostic device that measures a biomarker (CRP concentration) in serum. The "ground truth" for such a device is typically established by comparing its results to a recognized reference method or clinically validated samples with known CRP concentrations, not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable/not provided. Adjudication methods like 2+1 or 3+1 are common in studies involving expert interpretation of images or clinical cases, not typically for quantitative in vitro diagnostic assays measuring a biomarker.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are relevant for devices that are interpreted by human readers (e.g., AI in radiology). This device is a biochemical assay.
6. Standalone (Algorithm Only) Performance Study
Yes, the information provided describes the standalone performance of the Wako CRP test, as it is an in vitro diagnostic assay that produces quantitative results. The performance characteristics mentioned (linearity, minimum detectable level, precision) are inherent to the algorithm/assay itself, without human interpretation in the loop.
7. Type of Ground Truth Used
The "ground truth" for an in vitro diagnostic device like the Wako CRP test would be established by:
- Reference materials/calibrators with known CRP concentrations: Used to establish linearity and calibrate the assay.
- Comparison to a legally marketed predicate device or a clinical reference method: To demonstrate substantial equivalence and accuracy.
- Clinical samples with CRP levels determined by a validated method.
The document implies the use of calibrators (Wako CRP Calibrator and Wako CRP Calibrator Set) to establish linearity and for the determination of CRP.
8. Sample Size for the Training Set
The document does not explicitly state a sample size for a "training set." For an in vitro diagnostic assay, the development process involves extensive internal validation and optimization, which could be considered analogous to training, but it's not typically described in terms of a "training set" in the same way an AI/ML algorithm would. The calibrator sets mentioned are used for the actual calibration of the assay during use, not for an initial "training" of the device algorithm itself.
9. How Ground Truth for the Training Set Was Established
As above, the concept of a "training set" in the AI/ML sense doesn't directly apply here. The "ground truth" for the calibrators would be established through careful analytical methods to assign precise CRP values to them, often traceable to international reference standards. The document mentions the use of "Wako CRP Calibrator Set" and "Wako single point CRP Calibrator," implying these are used to define the quantitative response of the assay.
§ 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).