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510(k) Data Aggregation
(273 days)
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.
This in vitro diagnostic device is intended for prescription use only.
The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312
R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
Device Name: Direct LDL Cholesterol (LDL)
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|---|
| Precision | Total CV % (within run, among run, among day) | Generally expected to be low for clinical assays, with specific targets often dependent on concentration levels. | QC 1 (92.0 mg/dl): 5.9% total CV |
| QC 2 (135.9 mg/dl): 4.6% total CV | |||
| QC 3 (186.7 mg/dl): 4.4% total CV | |||
| Serum pool 1 (65.0 mg/dl): 5.9% total CV | |||
| Serum pool 2 (154.0 mg/dl): 5.0% total CV | |||
| Serum pool 3 (200.1 mg/dl): 5.0% total CV | |||
| Serum pool 4 (343.7 mg/dl): 5.3% total CV | |||
| Linearity/Reportable Range | Linear Regression Correlation Coefficient (r) | Close to 1.0 (indicating a strong linear relationship) | r = 0.997 |
| Reportable Range | Defined range where results are linear. | 21 - 740 mg/dl | |
| Detection Limit | Limit of Blank (LoB) | Very low, ideally close to zero, to ensure no signal from blank. | 1.94 mg/dl |
| Limit of Detection (LoD) | Low enough to reliably detect the analyte. | 3.19 mg/dl | |
| Limit of Quantitation (LoQ) | Low enough for precise and accurate quantification at low concentrations (typically ≤20% imprecision). | 16.1 mg/dl (with ≤20% imprecision) | |
| Analytical Specificity | Interference (% of Control) | % of Control ± 10% for potential interferents at specified concentrations. | Hemoglobin: No significant interference up to 1000mg/dl. |
| Total Bilirubin: No significant interference up to 60mg/dl. | |||
| Conjugate Bilirubin: No significant interference up to 60mg/dl. | |||
| Triglycerides: No significant interference up to 500mg/dl. | |||
| Intralipid®: No significant interference up to 500mg/dl. | |||
| Ascorbic Acid: No significant interference up to 6mg/dl. | |||
| Method Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when compared to a predicate device, indicating substantial equivalence. | r = 0.998 (compared to predicate device) |
| Matrix Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when comparing serum and lithium heparin plasma, indicating equivalent performance across matrices. | r = 0.998 (serum vs. lithium heparin plasma) |
| Traceability | Conformance to reference materials/standards | Traceable to an internal master reference material. Not certified by CRMLN (stated as a disclaimer in labeling). | Traceable to an internal master reference. Labeling states "device has not been certified by the CRMLN." |
Study Details
- Sample size used for the test set and the data provenance:
- Precision (Analytical Performance): 80 determinations for each of 7 pools/QC levels (total of 560 determinations). The samples included control material and "unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges" (e.g.,
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(42 days)
For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and renal diseases and for the assessment for the risk of developing cardiovascular disease.
This in vitro diagnostic device is intended for Rx Only.
The Direct HDL Cholesterol (HDL) kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: CH8311
R1. Enzyme Reagent 1 4 x 20 ml
R2. Enzyme Reagent 2 4 x 9 ml
REAGENT COMPOSITION
R1. Enzyme Reagent 1 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid N-(2-hydroxy-3-Sulfopropyl)- 3,5-dimethoxyaniline, sodium salt (HDAOS) Cholesterol Esterase [E.C.3.1.1.13. Microorganism] Cholesterol Oxidase [E.C.1.1.3.6. Streptomyces sp] Catalase [E.C.1.11.1.6. Microbial] Ascorbate oxidase [EC.1.10.3.3. Acremonium sp.] Initial Concentration of Solution 100 mM, pH 6.6 (+25 °C) 0.7 mM ≥800 U/L ≥500 U/L ≥300 KU/L ≥3000 U/L
R2. Enzyme Reagent 2 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid 4-Aminoantipyrine Peroxidase [E.C.1.11.1.7, Horse Radish, +25°C] Sodium Azide Surfactants Initial Concentration of Solution 100 mM, pH 7.0 (+25 °C) 4.0 mM ≥3500 U/L 0.05 w/v % 1.4 % w/v %
This looks like a 510(k) summary for an in vitro diagnostic (IVD) device, specifically for a Direct HDL Cholesterol (HDL) test system. Since IVD devices, especially Class I, do not typically involve AI or machine learning components as described in the prompt's questions, many of the requested fields (such as "number of experts used to establish ground truth", "adjudication method", "MRMC study", "standalone performance", "training set size", and "how ground truth for training set was established") are not applicable.
However, I can extract the relevant information regarding acceptance criteria and performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (CV) @ 28 mg/dL | (Implied by context, typically need to be within acceptable clinical limits/manufacturer specs; often 0.95 and slope close to 1, intercept close to 0) | Y = 1.01x - 0.75, r = 0.994 |
| Matrix Comparison (Serum vs. Lithium Heparin Plasma) | (Implied: High correlation, e.g., r > 0.95 and slope close to 1, intercept close to 0) | Y = 0.99x + 2.18, r = 0.993 |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision/Reproducibility:
- Control material and human serum samples: 80 determinations per control level/serum pool (2 replicates/run x 2 runs/day x 20 days).
- Provenance: "unaltered human serum samples" and "control material." The documentation does not specify the country of origin of the human serum samples. The study design (testing over 20 non-consecutive days) suggests it's a prospective study for data collection, but the samples themselves could be retrospective.
- Linearity/Reportable Range:
- Samples: 11 levels, each run in replicates of five.
- Provenance: Low and high serum pool samples. Not specified for country of origin or retrospective/prospective.
- Detection Limit:
- Samples: 240 determinations (4 low-level samples) for LoD.
- Provenance: Not specified for country of origin or retrospective/prospective.
- Analytical Specificity (Interference):
- Samples: Spiked samples at 34.8 mg/dL and 70 mg/dL HDL Cholesterol concentrations. The number of individual samples is not explicitly stated.
- Provenance: Not specified for country of origin or retrospective/prospective.
- Method Comparison:
- Patient Samples: 103 serum patient samples.
- Provenance: Not specified for country of origin or retrospective/prospective.
- Matrix Comparison:
- Patient Samples: 45 matched patient sample pairs (serum and lithium heparin plasma).
- Provenance: Not specified for country of origin or retrospective/prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable as this is an in vitro diagnostic (IVD) device for quantitative biochemical analysis, not an AI/image-based diagnostic device requiring expert interpretation for ground truth. Ground truth is typically established by reference methods or validated laboratory measurements.
4. Adjudication Method for the Test Set:
- Not applicable for this type of IVD device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not applicable as this is an IVD device, not an AI-assisted diagnostic system involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This device is a standalone in the sense that its performance characteristics (precision, linearity, interference, method comparison) are evaluated for the device itself as an assay system. There is no "algorithm only" vs. "human-in-the-loop" distinction because it's a quantitative chemical assay.
7. The Type of Ground Truth Used:
- For precision, linearity, and detection limit: The "ground truth" is implied to be the actual concentration of HDL Cholesterol, which is determined by the preparation of controls, spiked samples, and dilutions, or by the inherent properties of the samples themselves, and measured by the device and predicate.
- For analytical specificity (interference): The ground truth is the presence/absence of interferents at specific concentrations and their impact on the HDL measurement.
- For method comparison: The "ground truth" for comparison is the measurement obtained from the predicate device (Randox Laboratories Ltd, Direct HDL Cholesterol reagent, K982341). This represents a legally marketed device against which equivalence is demonstrated.
- For matrix comparison: The ground truth for comparison is the measurement obtained from serum samples when comparing to plasma samples.
8. The Sample Size for the Training Set:
- Not applicable in the context of machine learning/AI where "training set" has a specific meaning. For an IVD, the development and optimization of the reagent formulation and assay parameters would be an analogous "training" phase, but it doesn't involve a distinct "training set" of patient data in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reasons as above. The "ground truth" for developing the assay itself would be established through chemical principles, optimization experiments, and validation against known standards and reference materials.
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