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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:

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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Teco Direct HDL/LDL Calibrator is used for the calibration of Teco Diagnostics' Direct HDL and Direct LDL Cholesterol Reagent Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL quantitative determination is used in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator

This document is a 510(k) premarket notification for a diagnostic reagent and calibrator (Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator). As such, it is not a study document that details acceptance criteria and performance of a device in the way a clinical trial or AI/ML device study would.

Therefore, the requested information elements (1-9) which are typically associated with performance studies of medical devices, especially AI/ML-driven ones, cannot be extracted from this regulatory approval letter.

Instead, this document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. The "Indications for Use" section specifies the intended purpose of the device: "quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma." It also mentions that "Low HDL cholesterol levels are associated with an increased risk" for coronary heart diseases, and the reagent set is intended for "in vitro diagnostic use only."

To provide the kind of detail requested about acceptance criteria and study performance, one would need to refer to the original 510(k) submission document (K050623), which would contain the performance data and equivalence claims against the predicate device. This approval letter references that submission but does not contain the detailed study information itself.

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Direct HDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum or plasma. HDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

The device is a system using the reagent and calibrator in combination to directly measure the HDL-Cholesterol. This is achieved by a homogenous method that directly measures serum HDL Cholesterol levels without the need for any off-line pretreatment or centrifugation steps. It employs a two-reagent system. The first reagent (R1) contains a combination of detergent, organic and inorganic phosphoric acid compounds, which specifically binds LDL, VLDL and chylomicrons leaving the HDL particles exposed. The second reagent (R2) contains enzymes, which then react with the HDLcholesterol present in the sample.

Here's a breakdown of the acceptance criteria and study information for the Direct HDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state the numerical acceptance criteria for precision and interference. It only states that the results were "within acceptable range." For method comparison, the implied criterion is a strong correlation, which the reported 0.9987 satisfies. The regression equation also indicates minimal bias.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 50 patient samples were used for the correlation (method comparison) study.
• Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the phrasing "using 50 patient samples" suggests it was likely prospective for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the document. The study relies on method comparison against a predicate device, not expert consensus for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth was established by comparison to a predicate device's measurements, not by human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in-vitro diagnostic device for quantitative determination of a biomarker, not an imaging device requiring human reader interpretation. Therefore, the effect size of human reader improvement with or without AI assistance is not relevant or measured.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done in the sense that the device's analytical performance (precision, linearity, sensitivity, interference) was evaluated independently. The method comparison study also assesses the device's performance against a reference method without human interpretation as part of the measurement process.

7. Type of Ground Truth Used

• The ground truth for the method comparison study was established by the measurements obtained from a legally marketed predicate device: HDL Cholesterol Plus (K000568) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche).
• For other analytical performance studies (precision, linearity, sensitivity, interference), the ground truth is typically derived from established laboratory protocols and reference materials but this is not explicitly detailed beyond stating the results were "within acceptable range."

8. Sample Size for the Training Set

• This information is not applicable or provided. This device is a chemical reagent system, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" would relate to its chemical formulation and optimization during development, not data-driven learning.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable or provided for the reasons stated in point 8.

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The K-ASSAY Direct HDL-Cholesterol reagent is intended for the quantitative in vitro determination of HDL-cholesterol in serum or plasma which is used in the diagnosis and treatment of lipid disorders.

The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

K-Assay Direct HDL-Cholesterol Reagent K-Assay Direct HDL-Cholesterol Calibrator

This document is a 510(k) clearance letter from the FDA for a medical device called the "K-Assay Direct HDL-Cholesterol Reagent and Calibrator". This type of document does not contain the detailed information about acceptance criteria or specific study results that you are requesting.

Here's why and what information is typically missing:

Why this document doesn't have the requested information:

• 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. It's not a pre-market approval (PMA) and doesn't require the same depth of clinical study data to be submitted or publicly summarized in the clearance letter itself.
• Regulatory Focus: The letter confirms that the device can be marketed because it meets the regulatory requirements for substantial equivalence. It refers to the "indications for use" but doesn't detail the specific performance studies that underpinned those claims.
• Proprietary Information: Detailed study results, acceptance criteria, and ground truth methodologies are often considered proprietary by the manufacturer and are submitted to the FDA confidentially. They are rarely fully disclosed in the public 510(k) clearance letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document only states the device's intended use for quantitative determination of HDL-cholesterol. It does not provide performance metrics like accuracy, precision, sensitivity, specificity, or the acceptance criteria for these.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for an in vitro diagnostic reagent like this. MRMC studies are typically for imaging devices where human interpretation is involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for an in vitro diagnostic reagent. Its performance is inherent to the chemical assay itself.
7. The type of ground truth used: Not mentioned. For a diagnostic assay, the "ground truth" would likely be established by a reference method for HDL-cholesterol.
8. The sample size for the training set: Not mentioned. In the context of an in vitro diagnostic reagent, there isn't typically a "training set" in the same way an AI algorithm has one. Performance is established through validation studies.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory status of the device but does not contain the detailed technical and scientific performance data or study design information you are looking for. To find such information, one would typically need to consult the device's Instructions For Use (IFU), peer-reviewed publications by the manufacturer, or the more detailed (and often redacted) 510(k) summary filed with the FDA, if available, though even that rarely contains all the detail requested.

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The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease.

Direct HDL is an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma. The Direct HDL assay is a two reagent format and depends on the properties of a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing the HDL cholesterol to react with cholesterol esterase and cholesterol oxidase, in the presence of chromogens to produce color. In addition to selectively disrupting the HDL lipoprotein particles, this unique detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicron lipoproteins by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL, and chylomicron lipoproteins, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.

This 510(k) submission describes the Direct HDL assay, an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Direct HDL assay," but does not provide the number of samples or subjects used in these studies.
• Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's an IVD device, the samples would likely be human serum or plasma.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• No. of Experts: Not applicable. This is an in vitro diagnostic assay that generates quantitative results. The "ground truth" for method comparison and precision studies is typically derived from the performance of a legally marketed predicate device (Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer) and established analytical control materials, respectively. Expert interpretation of images or clinical cases is not relevant for this type of device.
• Qualifications: Not applicable for this type of device study.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As this is an IVD assay providing quantitative values, there is no expert adjudication process in the traditional sense. The comparison is statistical against a predicate device or pre-defined analytical metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not done. MRMC studies are typically performed for imaging or interpretation devices where human readers assess cases, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is a quantitative chemical assay, not an imaging or interpretation aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, the entire study focuses on the standalone performance of the Direct HDL assay. Since it is an in vitro diagnostic assay, its performance is inherently "standalone" in that it produces a quantitative result without human intervention in the measurement process (though a human ultimately interprets the result in a clinical context). The studies evaluate the assay's analytical performance (correlation with a predicate, precision, linearity, sensitivity).

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • Method Comparison: The "ground truth" is established by the performance of the legally marketed Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer, which serves as the reference method.
  • Precision and Linearity: The ground truth for these studies is typically established by using certified control materials or spiked samples with known concentrations, or by statistical analysis of repeat measurements. These are analytical benchmarks, not clinical ground truth like pathology or outcome data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set. It is a chemical assay with a defined reagent formulation and analytical method.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device. The assay's performance characteristics are inherent to its chemical and enzymatic design.

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The Randox Liquid Direct HDL-Cholesterol (HDL-C) test kit is an in vitro diagnostic reagent for the quantitative determination of HDL-Cholesterol in human serum and plasma. Accurate measurement of HDL-C is of importance when assessing patient risk from coronary heart disease.

In this diagnostic test kit a method for direct measurement of HDL-C, without sample pretreatment is presented.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a "Direct HDL Cholesterol" device, informing the manufacturer that their device is substantially equivalent to legally marketed predicate devices.

The letter discusses regulatory classifications, general controls, and compliance requirements, but it does not include:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for ground truth establishment.
• Details about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This document is a regulatory approval notice, not a scientific study report or performance evaluation.

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