(41 days)
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of C-reactive protein in human serum.
The proposed test reagent (N Latex CRP mono Reagent) is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the quantitative defermination of C-reactive protein in human serum.
In the proposed product polystyrene particles coated with mouse monoclonal Y antibodies to C-reactive protein are agglutinated when mixed with samples containing C-reactive proteins. The intensity of the resulting scattered light in the nephelometer is dependent upon the C-reactive protein content so that, by comparison to standards of known concentration the C-reactive protein content of a sample can be determined.
The provided text describes a 510(k) summary for the N Latex CRP mono Reagent, an in vitro diagnostic device. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds for correlation or precision that the device needed to meet. Instead, it reports the performance characteristics observed in studies. The legal standard for 510(k) is "substantial equivalence" to a legally marketed predicate device, rather than meeting specific performance criteria.
| Performance Metric | Reported Device Performance (N Latex CRP mono Reagent) |
|---|---|
| Correlation | |
| Correlation Coefficient | 0.98 (vs. N Latex CRP) |
| Y-intercept | 1.43 (vs. N Latex CRP) |
| Slope | 0.95 (vs. N Latex CRP) |
| Precision | |
| Intra-assay (n=20) | 4.0% CV (at ~15 mg/L), 2.3% CV (at ~25 mg/L), 4.4% CV (at ~60 mg/L) |
| Inter-assay (n=10) | 2.6% to 5.7% CV (across ~10, 15, 25, 45, 60 mg/L) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 71 serum samples were used for the correlation study. The precision studies used samples with various CRP concentrations, tested 20 times for intra-assay and 10 times for inter-assay precision.
- Data Provenance: Not specified. The document does not indicate the country of origin of the samples or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is an in vitro diagnostic reagent measuring C-reactive protein (CRP) levels. Ground truth is established by the measurement itself, not by expert interpretation of images or clinical assessments in the way it would be for a diagnostic imaging AI. The "ground truth" for the correlation study would implicitly be the results obtained by the predicate device (N Latex CRP).
4. Adjudication Method for the Test Set
This information is not applicable for this type of in vitro diagnostic device, as there's no interpretation by multiple readers requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the device is an in vitro diagnostic reagent, not an AI for image analysis or clinical decision support that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
The reported performance characteristics (correlation and precision) are essentially standalone performance evaluations of the N Latex CRP mono Reagent itself, compared to a predicate device or against itself under various conditions. There is no human-in-the-loop component for the measurement of CRP by this device.
7. Type of Ground Truth Used
For the correlation study, the "ground truth" was implicitly established by the measurements obtained using the legally marketed predicate device, N Latex CRP. For precision studies, the measurements themselves define the performance.
8. Sample Size for the Training Set
This information is not applicable. This device is a reagent for a specific biochemical measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the device is inherent in its chemical formulation and calibration process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8. The device's calibration refers to a "lot independent standard" rather than a training set with established ground truth.
§ 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).