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510(k) Data Aggregation
(123 days)
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease.
Medica's HDL cholesterol reagent consists of two parts R1 and R2. The first step involves the removal of other non-HDL lipoproteins via selective reaction with reagent R1. In the second step, the selective detergent in R2 solubilizes the HDL cholesterol specifically, which then reacts with a chromagen to develop a color that can be read optically at 600nm. The intensity of the color is proportional to the concentration of HDL cholesterol in the sample.
Here's an analysis of the acceptance criteria and study details for the Medica Corporation EasyRA HDL Cholesterol Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (a reagent for an in-vitro diagnostic test), acceptance criteria are typically related to analytical performance characteristics. The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold, but rather reports the performance demonstrated, implying that these levels met regulatory expectations for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Linear throughout clinical range | 2 to 150 mg/dL |
| Within-Run Precision | CV% ≤ 3% (typical for QC materials) | Bio-Rad L1: 1.9% - 2.2% CV% |
| Randox L2: 1.0% - 1.5% CV% | ||
| Total Precision | CV% ≤ 3% (typical for QC materials) | Bio-Rad L1: 2.47% - 2.51% CV% |
| Randox L2: 1.91% - 2.12% CV% | ||
| Method Comparison | Excellent correlation with predicate device | "correlated excellently" with predicate device (Genzyme HDL Cholesterol Reagent for Cobas-Mira) |
| Sample Carryover | No evidence of carryover | No evidence of sample carryover |
| Analytical Sensitivity (Limit of Detection) | Low limit needed for clinical relevance | 0.86 mg/dL |
| Functional Sensitivity | Low limit needed for clinical relevance | 1.3 mg/dL |
| Interference | No significant interference at specified concentrations | Hemoglobin: No interference up to 500mg/dl |
| Bilirubin: No interference up to 32.5mg/dl | ||
| Lipemia: No interference up to 1000mg/dl |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity: Not explicitly stated beyond "commercial linearity standards." These are typically synthetic or pooled human samples.
- Within-Run Precision: Five replicates of two levels of commercial serum-based QC material tested each day for five days. This is a total of 5 replicates * 2 levels * 5 days = 50 measurements per analyzer, across three analyzers. So, 150 data points in total for each QC level across the three analyzers. The samples were "commercial serum-based Quality control material". The provenance is not specified (e.g., country of origin, retrospective/prospective), but given they are commercial QC materials, they would likely be manufactured under controlled conditions.
- Total Precision: Two levels of commercial serum-based QC material tested in duplicate twice daily for 20 days. This is a total of 2 replicates * 2 times/day * 20 days = 80 measurements per analyzer, across three analyzers. So, 240 data points in total for each QC level across the three analyzers. The samples were "commercial serum-based Quality control material." Provenance not specified.
- Method Comparison: "At least 40 samples" were tested. The provenance is not specified, but these would typically be human serum samples, likely collected prospectively or retrospectively from a local population at the time of the study.
- Sample Carryover: "Eleven samples" (L, M, H range) were analyzed. Provenance not specified.
- Sensitivity: "20 replicates of reagent grade water." Provenance is irrelevant as it's a non-biological sample.
- Interference Testing: Not specified, but involved specific concentrations of hemoglobin, bilirubin, and intralipid, likely spiked into a normal serum matrix.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (a diagnostic reagent for a chemistry analyzer) does not typically rely on human expert interpretation for "ground truth" in the same way an imaging or pathology device would. The "ground truth" for the test set is established by:
- Reference Methods/Materials: For linearity, it's NIST-traceable commercial linearity standards.
- Predicate Device: For method comparison, the "ground truth" is established by the measurements from the legally marketed predicate device (Genzyme HDL Cholesterol Reagent on a Cobas-Mira analyzer).
- Known Concentrations: For precision, it's known concentrations in commercial quality control materials.
- Spiked Samples: For interference, it's known concentrations of interferents added to serum.
Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth is not applicable in this context. The accuracy of the "ground truth" relies on the validated performance of the reference methods, predicate device, and QC materials used.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. Since this is an analytical performance study of an in-vitro diagnostic reagent, such adjudication methods are not applicable. The measurements are quantitative and objectively determined by the analyzer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for devices where human readers or interpreters interact with the device's output (e.g., interpreting medical images with or without AI assistance). This device is a reagent for an automated chemistry analyzer, producing quantitative numerical results, not requiring human interpretation as part of the primary diagnostic step.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are essentially standalone performance studies of the reagent on the EasyRA analyzer. The performance metrics (linearity, precision, method comparison, sensitivity, interference) evaluate the reagent and analyzer system's ability to accurately and precisely measure HDL cholesterol without human intervention affecting the measurement itself. The "algorithm" here is the chemical reaction and photometric measurement process implemented by the reagent and analyzer.
7. Type of Ground Truth Used
- NIST-traceable commercial linearity standards: For linearity.
- Commercial serum-based Quality control material with known target values: For precision.
- Measurements from a legally marketed predicate device (Genzyme HDL Cholesterol Reagent on Cobas-Mira): For method comparison.
- Reagent grade water: For sensitivity.
- Serum samples spiked with known concentrations of interferents: For interference testing.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development. For an IVD reagent, method development involves extensive experimentation and optimization, but it's not typically quantified as a "training set" in the same way a machine learning algorithm would have one. The performance studies described are validation studies, not training studies.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is described for this type of IVD reagent, this question is not fully applicable. The development process would involve establishing "ground truth" through various analytical chemistry principles, using reference materials, and comparing results to established methods to optimize the reagent's formulation and reaction conditions.
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