(113 days)
Ouantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.
Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.
Ouantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
When a sample containing CRP is mixed with the Latex Reagent and the Reaction Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.
Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.
Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.
The quantex CRP High Sensitivity device is an in vitro diagnostic assay for the quantitative determination of C-Reactive Protein (CRP) in human serum. This summary describes the acceptance criteria and the study that demonstrates the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Although explicit "acceptance criteria" are not formally presented as thresholds in the provided text, the study aims to demonstrate substantial equivalence to a predicate device. Therefore, the performance metrics for comparison are derived from the observed results of the method comparison and precision studies. The implicit acceptance criteria are that the device's performance should be similar to or better than the predicate device and show acceptable precision for diagnostic use.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (quantex CRP High Sensitivity) |
|---|---|---|
| Method Comparison (vs. Predicate Device) | ||
| ILab 900/1800 System | ||
| Slope | Close to 1.0 | 0.948 |
| Intercept | Close to 0 | -0.105 |
| Correlation Coefficient (r) | Close to 1.0 (indicating strong correlation) | 0.9969 |
| ILab 600 System | ||
| Slope | Close to 1.0 | 0.957 |
| Intercept | Close to 0 | -0.074 |
| Correlation Coefficient (r) | Close to 1.0 (indicating strong correlation) | 0.9989 |
| Precision (Within-run CV%) | ||
| ILab 900/1800 System | ||
| Control 1 (2.39 mg/L CRP) | Low CV% (indicating high precision) | 1.25% |
| Control 2 (5.87 mg/L CRP) | Low CV% (indicating high precision) | 0.88% |
| ILab 600 System | ||
| Control 1 (2.32 mg/L CRP) | Low CV% (indicating high precision) | 2.11% |
| Control 2 (5.82 mg/L CRP) | Low CV% (indicating high precision) | 1.96% |
| Precision (Total CV%) | ||
| ILab 900/1800 System | ||
| Control 1 (2.39 mg/L CRP) | Low CV% (indicating high precision) | 3.32% |
| Control 2 (5.87 mg/L CRP) | Low CV% (indicating high precision) | 1.50% |
| ILab 600 System | ||
| Control 1 (2.32 mg/L CRP) | Low CV% (indicating high precision) | 2.50% |
| Control 2 (5.82 mg/L CRP) | Low CV% (indicating high precision) | 2.09% |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set:
- ILab 900/1800: 156 samples
- ILab 600: 55 samples
- Data Provenance: The document does not explicitly state the country of origin for the samples or whether the study was retrospective or prospective. It is implied to be clinical samples used for method comparison on laboratory instruments.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the method comparison appears to be the results obtained from the predicate device (N High Sensitivity CRP).
4. Adjudication Method for the Test Set
- No adjudication method is described, as the ground truth is based on the predicate device's measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was performed or described. This device is an in vitro diagnostic assay, not an imaging or interpretation device that would typically involve human readers.
6. Standalone Performance Study
- The performance data presented for "quantex CRP High Sensitivity" are standalone in the sense that they represent the algorithm's (or assay's) performance in determining CRP levels, independent of human interpretation beyond typical laboratory procedures. The method comparison specifically evaluates the device's results against those of a predicate device, which can be considered a form of standalone evaluation against a gold standard (the predicate).
7. Type of Ground Truth Used
- The ground truth used for the method comparison study was the measurements obtained from the predicate device (N High Sensitivity CRP). For the precision studies, the 'ground truth' is the mean value of the controls (2.39 mg/L and 5.87 mg/L for ILab 900/1800; 2.32 mg/L and 5.82 mg/L for ILab 600), which are established values for quality control materials.
8. Sample Size for the Training Set
- The provided document does not specify a separate "training set" or its sample size. For an in vitro diagnostic assay like this, development typically involves internal validation and optimization, but the document focuses on the performance studies for regulatory submission, which represent the "test set" or verification/validation data.
9. How Ground Truth for the Training Set Was Established
- As no separate training set is explicitly mentioned or detailed in the document, the method for establishing its ground truth is not provided.
§ 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).