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510(k) Data Aggregation
(46 days)
K830207A, K963213
The Raichem HDL-Cholesterol Direct Reagent is intended for the quantitative determination of HDL-Cholesterol in serum or plasma. The Raichem HDL-Cholesterol Calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.
The Raichem HDL-Cholesterol Direct test is based upon two sets of reaction sequences. In the first set of reactions Chylomicrons. VLDL selectively react with cholesterol esterase and are then eliminated from the reaction scheme. The addition of the second reagent causes the reaction of HDL-Cholesterol with cholesterol esterase and the subsequent production of color. The resultant increase in absorbance is directly proportional to the concentration of HDL-Cholesterol in the sample. The Raichem HDL-Cholesterol Calibrator is a serum calibrator used for the calibration of the Raichem HDL-Cholesterol Direct assay.
Acceptance Criteria and Device Performance Study for Raichem HDL-Cholesterol Direct Reagent
1. Table of Acceptance Criteria and Reported Device Performance
This device is an in-vitro diagnostic (IVD) reagent for determining HDL-Cholesterol levels. The acceptance criteria are based on performance characteristics relevant to an IVD, such as precision, linearity, and comparison with a reference method.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Precision | Within-Run CV% for various HDL-C levels | Meets NCCLS EP5-T2 guidelines. | |
| - For HDL-C ~33 mg/dL | CV% = 0.8% | ||
| - For HDL-C ~51 mg/dL | CV% = 0.6% | ||
| Total CV% for various HDL-C levels | |||
| - For HDL-C ~33 mg/dL | CV% = 2.7% | ||
| - For HDL-C ~51 mg/dL | CV% = 2.6% | ||
| Calibrator Standardization | Traceable to National Institute of Standards Standard Reference Material (1951a); Meets CRMLN "HDL Cholesterol Method Evaluation Protocol for Manufacturers" requirements. | Confirmed by ultracentrifugation, traceable to NIST SRM 1951a. Procedures meet CRMLN August 1995 requirements. | |
| Lower Detection Limit | Not explicitly stated as an "acceptance criterion" but determined as a performance characteristic. | Determined to be 1 mg/dL | |
| Linearity | Not explicitly stated as an "acceptance criterion" but determined as a performance characteristic. | 1 to 150 mg/dL | |
| Comparison to CDC Designated Reference Method | Correlation Coefficient (r) to CDC method | r = 0.987 | Strong correlation, indicating good agreement. |
| Regression Equation to CDC method | $y = 0.9488x + 2.0$ | Slope close to 1, intercept close to 0; indicates good accuracy. | |
| Comparison to Predicate Device (Raichem HDL-Cholesterol Reagent - dextran sulfate method) | Correlation Coefficient (r) to predicate device | r = 0.988 | Strong correlation, indicating substantial equivalence. |
| Regression Equation to predicate device | $y = 1.011x + 0.192$ | Slope close to 1, intercept close to 0; indicates good agreement. |
2. Sample Size and Data Provenance
- Test Set (Precision): 48 runs over 24 days. The specific number of distinct patient samples used for precision is not explicitly stated, but typically multiple aliquots from a few representative samples would be run repeatedly. The provenance of these samples (e.g., country of origin) is not mentioned. Likely prospective data collected for the study.
- Test Set (Comparison Testing - CDC Method): 47 sample pairs. The provenance is not mentioned. Likely prospective data collected for the study.
- Test Set (Comparison Testing - Predicate Device): 48 sample pairs. The provenance is not mentioned. Likely prospective data collected for the study.
3. Number of Experts and Qualifications for Ground Truth
For an in-vitro diagnostic device like the Raichem HDL-Cholesterol Direct Reagent, ground truth is established by a reference method rather than expert interpretation of images or clinical assessments.
- For Comparison to the CDC Designated Comparison Method: The ground truth for this comparison was established by the "CDC Designated Comparison Method," which is performed by a laboratory that is part of the Cholesterol Reference Method Laboratory Network (CRMLN). This method is standardized to the CDC reference method for HDL-Cholesterol. No individual "experts" are identified, but rather the accredited laboratory and its reference method serve as the gold standard.
- For Calibrator Standardization: The ground truth for the calibrator value is established by ultracentrifugation and is traceable to the National Institute of Standards Standard Reference Material (1951a). This also relies on established measurement techniques and certified reference materials, not individual experts.
4. Adjudication Method
Not applicable. For IVD devices, ground truth is typically established by reference methods or certified materials, not through adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. Standalone Performance
Yes, the studies conducted represent the standalone performance of the algorithm (reagent in this case) as it measures HDL-Cholesterol concentrations directly from serum or plasma samples. The reported precision, linearity, lower detection limit, and comparison with reference methods are all measures of the device's standalone performance.
7. Type of Ground Truth Used
The type of ground truth used is:
- Reference Method/Standard:
- For comparison testing, the "CDC Designated Comparison Method" (standardized to the CDC reference method for HDL-Cholesterol) served as the gold standard.
- For calibrator standardization, ultracentrifugation, traceable to the National Institute of Standards Standard Reference Material (1951a), was used.
8. Sample Size for the Training Set
Not applicable. This device is an in-vitro diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and analytical validation, not statistical learning from data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device. The scientific principles and validation of the chemical reactions, along with the standardization of the calibrator against established reference methods, dictate its performance.
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