(42 days)
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum and plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
C-Reactive Protein is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 340 nm and 700 nm, which correlates with the concentration of C-reactive protein in the sample.
The Abbott Laboratories C-Reactive Protein (CRP) assay's acceptance criteria are based on demonstrating substantial equivalence to a predicate device, the Boehringer Mannheim® C-Reactive Protein assay (K930621) on the Hitachi® 717 Analyzer.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similar performance characteristics to predicate device. | The C-Reactive Protein assay method comparison yielded acceptable correlation with the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer. Correlation coefficient = 0.9963, slope = 1.093, and Y-intercept = 0.203 mg/dL. |
| Precision | Acceptable within-run, between-run, and between-day precision. | Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 control is 4.5% and Level 2/Panel 402 is 2.8%. |
| Assay Range | Defined assay range. | The C-Reactive Protein assay range is up to 12.68 mg/dL. |
| Limit of Quantitation (Sensitivity) | Defined limit of quantitation. | The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.263 mg/dL. |
| Methodology | In vitro immunoturbidimetric method. | Both assays are in vitro immunoturbidimetric methods and are based on the light scattering properties of antigen-antibody complexes. |
| Intended Use | Quantitative determination of C-reactive protein in human serum and plasma. | The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum and plasma. Both assays can be used for this purpose. |
| Clinical Results | Similar clinical results. | Both assays yield similar clinical results. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size used for the comparative performance and precision studies (test set). It mentions "two levels of control material" for precision studies but does not specify the number of samples for the method comparison study.
The data provenance is not explicitly stated in terms of country of origin, but it is implied to be prospective as performance studies "were conducted using the AEROSET™ System" and "precision studies were conducted" specifically for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of in vitro diagnostic assay. Ground truth for a C-reactive protein assay is established by the direct measurement of the analyte using a reference method or a validated comparator device, not by expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for this type of in vitro diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation by radiologists) where multiple experts might disagree. For quantitative assays, the comparison is against the results of the predicate device.
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 information is not applicable. This is an in vitro diagnostic device for quantitative determination of a biomarker, not an AI-powered image analysis or diagnostic aid that involves human readers or improved human performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, a standalone performance evaluation was done for the C-Reactive Protein assay. The studies described (comparative performance, precision, assay range, sensitivity) assess the device's performance as an algorithm/instrument system for measuring CRP levels, without human intervention in the result determination phase.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the comparative performance study was the quantitative results obtained from the Boehringer Mannheim® C-Reactive Protein assay on the Hitachi® 717 Analyzer (predicate device). This is a common method for establishing "ground truth" when demonstrating substantial equivalence for in vitro diagnostic devices. For precision, the "ground truth" is the inherent variability of the assay itself when measuring known control materials.
8. The Sample Size for the Training Set
The document does not provide information regarding a specific "training set" or its sample size. This is typical for traditional in vitro diagnostic assays. The device's performance is validated against established benchmark methods rather than being "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of machine learning, this question is not applicable. The device's underlying principles are based on established immunoturbidimetric methods and chemical reactions, not on data-driven training to learn a specific task.
§ 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).