(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., |
§ 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).