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510(k) Data Aggregation
(83 days)
HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases,
HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.
Hemos IL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.
The HS-CRP is a latex particle enhanced immunoturbidimetric assay to quantify CRP in When a plasma containing CRP is mixed with the Latex Reagent and the Reaction plasma. 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. The test range is well suited to cover apparent normality as well as the requirements as a marker of infectious and inflammatory diseases.
Here's a breakdown of the acceptance criteria and study information for the HemosIL High Sensitivity - C Reactive Protein device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it presents performance data in comparison to a predicate device and precision data. The implicit acceptance criterion is "substantial equivalence" to the predicate device.
| Performance Metric | Implicit Acceptance Criteria (based on predicate equivalence and typical assay requirements) | Reported Device Performance (HemosIL High Sensitivity - C Reactive Protein) |
|---|---|---|
| Method Comparison (vs. Predicate Device) | ||
| Slope (ACL 9000) | Close to 1.0 | 0.972 |
| Intercept (ACL 9000) | Close to 0.0 | -0.070 |
| Correlation Coefficient (r) (ACL 9000) | High (e.g., >0.95 or >0.97) | 0.9950 |
| Slope (ACL Futura) | Close to 1.0 | 0.942 |
| Intercept (ACL Futura) | Close to 0.0 | -0.027 |
| Correlation Coefficient (r) (ACL Futura) | High (e.g., >0.95 or >0.97) | 0.9945 |
| Precision (Within Run CV%) | ||
| Low HS-CRP Control (ACL 9000) | Low (e.g., <5%) | 1.75% |
| High HS-CRP Control (ACL 9000) | Low (e.g., <5%) | 1.01% |
| Low HS-CRP Control (ACL Futura) | Low (e.g., <5%) | 3.04% |
| High HS-CRP Control (ACL Futura) | Low (e.g., <5%) | 3.42% |
| Precision (Total CV%) | ||
| Low HS-CRP Control (ACL 9000) | Low (e.g., <10%, ideally <5%) | 2.57% |
| High HS-CRP Control (ACL 9000) | Low (e.g., <10%, ideally <5%) | 1.50% |
| Low HS-CRP Control (ACL Futura) | Low (e.g., <10%, ideally <5%) | 3.42% |
| High HS-CRP Control (ACL Futura) | Low (e.g., <10%, ideally <5%) | 3.63% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 153 samples were used for the method comparison study. The sample size for the precision studies is not explicitly stated as a number of individual patient samples, but rather as "multiple runs using two levels of control."
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to an in vitro diagnostic (IVD) device like a CRP assay. The "ground truth" for the method comparison is the measurement obtained from the predicate device. For precision, the control material itself acts as the reference. Therefore, no external experts were used to establish ground truth in the way one might for diagnostic imaging or clinical assessment.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD device measuring a biochemical marker, there is no expert adjudication process for the test results in the way there would be for subjective interpretations (e.g., radiology reads). The predicate device's readings are the reference.
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
Not applicable. This is an automated in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (method comparison and precision) represent the standalone performance of the HemosIL High Sensitivity - C Reactive Protein device. It is an automated system designed to provide quantitative results directly from plasma samples.
7. The Type of Ground Truth Used
- For the method comparison study, the "ground truth" was established by the predicate device (N High Sensitivity CRP). The performance of the new device was compared to that of an already legally marketed and accepted device.
- For the precision studies, the "ground truth" was represented by the assigned values of the control materials (Low HS-CRP Control and High HS-CRP Control). These controls typically have a known, target concentration of the analyte.
8. The Sample Size for the Training Set
Not applicable. This is a traditional immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. The device's performance is based on its chemical and optical characteristics, which are validated through analytical studies like those presented.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
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