(191 days)
EasyRA Calcium Reagent is intended for the quantitative determination of total calcium concentration in serum using the Medica EasyRA Chemistry Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). For in-vitro diagnostic use only. For Professional use only.
The EasyRA Cholesterol Reagent is intended for the quantitative determination of cholesterol in human serum on the Medica EasyRA Chemistry analyzer to screen for elevated cholesterol as a risk factor in coronary artery disease.
For in-vitro diagnostic use only. For Professional Use Only.
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Here's a summary of the acceptance criteria and study information for the EasyRA Calcium Reagent and EasyRA Cholesterol Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicit or Implied) | EasyRA Calcium Reagent Performance | EasyRA Cholesterol Reagent Performance |
|---|---|---|---|
| Linearity | Must be linear within specified ranges. | Linear from 1mg/dL to 15mg/dL. | Linear from 10mg/dL to 600mg/dL. |
| Within Run Precision | No explicit numerical criteria stated, but typically demonstrated by low SD/CV values at various QC levels. | QC Level 12.81 mg/dL: SD 0.23 mg/dL, CV 1.8% | |
| QC Level 9.73 mg/dL: SD 0.19 mg/dL, CV 1.9% | |||
| QC Level 5.24 mg/dL: SD 0.17 mg/dL, CV 3.3% | QC Level 215.90 mg/dL: SD 4.13 mg/dL, CV 1.9% | ||
| QC Level 168.05 mg/dL: SD 1.76 mg/dL, CV 1.0% | |||
| QC Level 105.70 mg/dL: SD 1.34 mg/dL, CV 1.3% | |||
| Total Imprecision | No explicit numerical criteria stated, but typically demonstrated by low SD/CV values at various QC levels. | QC Level 11.78 mg/dL: SD 0.16 mg/dL, CV 1.33% | |
| QC Level 9.03 mg/dL: SD 0.13 mg/dL, CV 1.46% | |||
| QC Level 5.95 mg/dL: SD 0.12 mg/dL, CV 1.95% | QC Level 168.5 mg/dL: SD 2.5 mg/dL, CV 1.5% | ||
| QC Level 302.9 mg/dL: SD 3.6 mg/dL, CV 1.2% | |||
| QC Level 106.2 mg/dL: SD 1.3 mg/dL, CV 1.2% | |||
| Method Comparison | "Correlated excellently" with the predicate device (Roche COBAS MIRA analyzer). | Correlated excellently with the predicate device. | Correlated excellently with the predicate device. |
| Sample Carryover | No evidence of sample carryover. | No evidence of sample carryover. | No evidence of sample carryover. |
| Interference Testing | No interference from specified substances up to certain concentrations. | Hemoglobin: no interference up to 500 mg/dL | |
| Bilirubin: no interference up to 20 mg/dL | |||
| Triglycerides: no interference up to 2250 mg/dL | Hemoglobin: no interference up to 500 mg/dL | ||
| Bilirubin: no interference up to 5 mg/dL | |||
| Lipemia: no interference up to 2250 mg/dL | |||
| Glucose: no interference up to 600 mg/dL | |||
| Ascorbic Acid: no interference up to 9 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity: The number of unique samples is not specified, but the study used "NIST-traceable commercial linearity standards." The data provenance (country, retrospective/prospective) is not explicitly stated.
- Within Run Precision: Twenty replicates of three levels of commercial human-based QC material were tested. The provenance of the QC material is not specified, but it's "commercial human-based."
- Total Imprecision: Duplicate measurements of each of three levels of QC material were tested twice a day for 20 days. This means 3 levels * 2 replicates/day * 20 days = 120 measurements per reagent. The provenance of the QC material is not specified.
- Method Comparison: At least 40 samples for each analyte were tested. The data provenance is not specified.
- Sample Carryover: 11 samples (L, M, H) in a predefined sequence, tested twice in a single day. The data provenance is not specified.
- Interference Testing: The number of samples for each interfering substance is not explicitly stated, but it involved testing Hemoglobin, Bilirubin, Lipemia (Intralipid), Glucose, and Ascorbic Acid up to specified concentrations. The data provenance is not specified.
In general, the data provenance (country of origin, retrospective/prospective) for these studies is not explicitly mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The device is an in-vitro diagnostic reagent for quantitative measurement of analytes (Calcium and Cholesterol) in serum. The "ground truth" is established by reference methods, certified materials (like NIST-traceable standards), or comparison to a legally marketed predicate device, rather than human expert consensus on interpretations of images or complex clinical scenarios.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on analytical performance of a quantitative reagent, not on classifying or interpreting results where human adjudication would be necessary.
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
This information is not applicable. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic imaging or interpretation device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable to a chemical reagent. The device itself is the reagent used in an automated analyzer. The "standalone" performance refers to the analytical performance of the reagent on the EasyRA Chemistry Analyzer, which is precisely what the performance data describes (linearity, precision, interference, carryover). There is no "human-in-the-loop" aspect to the measurement itself; human operators are involved in running the analyzer and interpreting the quantitative results in a clinical context.
7. The Type of Ground Truth Used
- Linearity: NIST-traceable commercial linearity standards.
- Precision (Within Run & Total): Commercial human-based QC material with known (or established) values.
- Method Comparison: Analytical results obtained from the predicate device (Roche COBAS MIRA analyzer), which serves as the comparative "truth" for substantial equivalence.
- Interference Testing: Known concentrations of interfering substances added to samples to assess their impact on the measurement.
8. The Sample Size for the Training Set
This information is not applicable. This device is a chemical reagent and does not use machine learning or AI that requires a "training set" in the conventional sense. Its performance specifications are determined through analytical validation studies as detailed.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.