Search Results

In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.

Here's a breakdown of the acceptance criteria and study details for the HDL-Cholesterol Gen.4 device, extracted from the provided document:

Device: HDL-Cholesterol Gen.4
Type: In vitro diagnostic test for the quantitative determination of HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

Acceptance Criteria and Reported Device Performance

• PreciControl ClinChem Multi 1 (Mean 28.0 mg/dL): SD 0.20 mg/dL, CV 0.7%
• PreciControl ClinChem Multi 2 (Mean 68.1 mg/dL): SD 0.44 mg/dL, CV 0.6%
• Human Serum 1 (Mean 9.48 mg/dL): SD 0.17 mg/dL, CV 1.8%
• Human Serum 2 (Mean 40.5 mg/dL): SD 0.26 mg/dL, CV 0.7%
• Human Serum 3 (Mean 59.4 mg/dL): SD 0.32 mg/dL, CV 0.5%
• Human Serum 4 (Mean 79.4 mg/dL): SD 0.51 mg/dL, CV 0.6%
• Human Serum 5 (Mean 141 mg/dL): SD 0.83 mg/dL, CV 0.6%
  Intermediate Precision:
• PreciControl ClinChem Multi 1 (Mean 28.4 mg/dL): SD 0.30 mg/dL, CV 1.1%
• PreciControl ClinChem Multi 2 (Mean 66.4 mg/dL): SD 0.9 mg/dL, CV 1.4%
• Human Serum 1 (Mean 9.48 mg/dL): SD 0.20 mg/dL, CV 2.2%
• Human Serum 2 (Mean 40.7 mg/dL): SD 0.33 mg/dL, CV 0.8%
• Human Serum 3 (Mean 59.4 mg/dL): SD 0.40 mg/dL, CV 0.7%
• Human Serum 4 (Mean 79.4 mg/dL): SD 0.65 mg/dL, CV 0.8%
• Human Serum 5 (Mean 141 mg/dL): SD 1.07 mg/dL, CV 0.8% |
  | Analytical Sensitivity (LoB, LoD, LoQ) | LoB, LoD, and LoQ should be below the claimed measuring range. | LoB Observed: 0.00 mg/dL (Claim: 3.09 mg/dL)
  LoD Observed: 0.50 mg/dL (Claim: 3.09 mg/dL)
  LoQ Observed: 2.89 mg/dL (Claim: 3.09 mg/dL) |
  | Linearity/Assay Reportable Range | Measurements should be linear across the claimed measuring range (3.09 to 150 mg/dL), with good correlation and low deviation. | Serum: Slope 1.020, Intercept -0.399, Correlation Coefficient (r2) 0.9992, Repeatability 1.5%
  Plasma: Slope 1.022, Intercept -0.173, Correlation Coefficient (r2) 0.9929, Repeatability 0.8%
  Claimed Measuring Range: 3.09 to 150 mg/dL (for both serum and plasma).
  Nonlinearity did not deviate by more than 10%. |
  | Endogenous Interferences | No significant interference (bias >10%) from common interferents like hemolysis, lipemia, icterus, and triglycerides at specified levels. | Hemolysis: No Interference up to 1200 H index
  Lipemia: No Interference up to 2000 L index
  Unconjugated Bilirubin: No Interference up to 60 I index
  Conjugated Bilirubin: No Interference up to 60 I index
  Triglycerides: No Interference up to 1200 mg/dL |
  | Exogenous Interferences (Drugs) | No significant interference from a panel of common drugs at specified concentrations. | Results provided in Table 7 (specific details of "no interference" for each drug are implied by listing them in a "Test Concentrations Results" table within the interference section, assuming they met the 10% bias criterion for non-interference). |
  | Method Comparison to Predicate | Strong correlation with a legally marketed predicate device, with acceptable bias at medical decision points. | Regression Analysis (HDL-Cholesterol Gen.4 vs. Predicate): y = 0.956x - 0.949, r = 0.995
  Bias at medical decision points:
  -6.7 % at 40.2 mg/dL
  -6.0 % at 59.9 mg/dL |
  | Matrix Comparison | Acceptable correlation between serum and various plasma anticoagulant types. | Serum vs. Serum Gel Separation: y = 0.99x - 0.33, r = 0.999
  Serum vs. Li-heparin: y = 0.99x - 0.32, r = 1.000
  Serum vs. K2-EDTA: y = 0.98x - 0.70, r = 0.999
  Serum vs. K3-EDTA: y = 0.95x - 0.08, r = 0.999 |

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Precision (Repeatability & Intermediate Precision): 5 human serum pools and 2 control samples were used. Tested for 21 days with 4 replicates/day. Data provenance is not explicitly stated as country of origin, but implied to be from a laboratory setting (likely in the US or Germany, given Roche's locations). The nature of the study (analyzing human serum pools and controls) suggests prospective data collection for evaluating device performance.
   • Analytical Sensitivity (LoB, LoD, LoQ):
     • LoB: One analyte-free sample. Measured 10-fold in 6 runs over 3 days, per reagent lot (total 60 measurements per lot).
     • LoD: Five samples with low-analyte concentration. Measured two-fold in 6 runs over 3 days, per reagent lot (total 60 measurements per lot).
     • LoQ: A low-level sample set prepared by diluting 5 human serum samples. Tested in 5 replicates per sample on 5 days.
   • Linearity/Assay Reportable Range: Dilution series prepared using 1 serum pool and 1 plasma pool. The dilution series contained 11 concentrations for serum and 15 concentrations for plasma.
   • Endogenous Interferences: Two human serum pools spiked with HDL-Cholesterol and interfering substances.
   • Exogenous Interferences (Drugs): Two human serum sample pools.
   • Method Comparison to Predicate: 111 routine laboratory serum samples. Additionally, 4 samples spiked with high human serum HDL-Cholesterol and 1 sample diluted with 0.9% NaCl. Data provenance is not explicitly stated as country of origin, but implied to be from a laboratory setting. The use of "routine laboratory serum samples" suggests retrospective collection, though the spiking and dilution aspects are prospective for the study design.
   • Matrix Comparison: 38 paired samples (serum and plasma) from single donors.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For this type of in vitro diagnostic device (quantitative measurement of a biomarker), "ground truth" is typically established by reference methods or validated comparative methods, not by human expert consensus or clinical adjudication as would be seen in imaging diagnostics.
   • The predicate device (Ultra N-geneous HDL Cholesterol Reagent, K021316) serves as a comparative "ground truth" for the method comparison study. The precision, sensitivity, linearity, and interference studies establish the intrinsic performance properties of the device against predefined analytical standards (e.g., CLSI guidelines).
   • Therefore, the concept of "experts" as in "a radiologist with 10 years of experience" is not directly applicable here. The experts involved would be laboratory scientists, biochemists, and statisticians who designed and executed the studies according to CLSI guidelines and interpreted the analytical data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where subjective interpretation is involved.
   • For this in vitro diagnostic device, measurements are quantitative, and "adjudication" is done through statistical analysis and adherence to predefined acceptance criteria based on established analytical guidelines (e.g., CLSI EP5-A3 for precision, CLSI EP17-A2 for detection limits, CLSI EP6-A for linearity). There is no "human adjudication" process for individual results as there would be for image interpretation.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images, and AI might assist or replace them. The HDL-Cholesterol Gen.4 is an in vitro diagnostic device that quantifies a substance in a laboratory sample; it does not involve human "readers" interpreting results in a subjective or visual manner that AI would enhance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance evaluation reports are inherently demonstrating the "standalone" performance of the analytical algorithm/reagent system. The studies evaluate the device's ability to accurately and precisely measure HDL-cholesterol concentrations in samples, independent of further human interpretation beyond routine laboratory operation and quality control. The reported results (e.g., mean, SD, CV, regression equations) directly reflect the algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Analytical Ground Truth: For the precision, sensitivity, linearity, and interference studies, the "ground truth" is based on the known concentrations of analytes in prepared samples (e.g., spiked samples, diluted samples, control materials) or the absence of analytes (blank samples), and performance is evaluated against established analytical standards and acceptable deviations.
   • Comparative Ground Truth: For the method comparison study, the predicate device (Ultra N-geneous HDL Cholesterol Reagent, K021316) served as the comparative "ground truth" or reference method for evaluating substantial equivalence. This is a common approach for 510(k) clearances.
   • No pathology or outcomes data was used for establishing the ground truth for device performance in this submission, as it's an analytical performance study for an IVD.

7. The sample size for the training set:

   • This document describes the pre-market notification (510(k)) studies for device validation, not the development or training of an AI algorithm. Therefore, there is no "training set" for an AI mentioned or implied in this submission. The device is a chemical reagent system, not an AI/ML independent medical device.

8. How the ground truth for the training set was established:

   • As noted above, no "training set" for an AI algorithm is described in this submission. The ground truth for the analytical studies described (e.g., precision, linearity) is based on the preparation of samples with known concentrations or comparative analysis against a validated predicate device, as per standard laboratory practice and CLSI guidelines.

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HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.

HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.

HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

This direct HDL Cholesterol method is a homogeneous assay without the need for any offline pretreatment or centrifugation steps. The method depends on a unique detergent which solubilizes only the HDL lipoprotein particles and releases HDL cholesterol to react with cholesterol esterase and cholesterol oxidase in the presence of chromogens, to produce a color product. The same detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicrons lipoproteins by adsorbing to their surfaces. A polyanion contained in the reagent enhances the selectivity for HDL cholesterol assay by complexing LDL, VLDL, and chylomicrons lipoproteins.

HDLX reagent is used to measure the cholesterol concentration by a timed-endpoint method. The SYNCHRON® System(s) automatically proportions the appropriate HDL cholesterol sample and reagent volumes into a cuvette. The ratio used is one part sample to 93 parts reagent. The System monitors the change in absorbance at 560 nanometers. This change in absorbance is directly proportional to the concentration of cholesterol in the sample and is used by the System to calculate and express the HDL-cholesterol concentration.

{
  "1_table_of_acceptance_criteria_and_reported_device_performance": {
    "Method Comparison Study (vs. Olympus HDLX Assay)": {
      "Platform": [
        "UniCel DxC 800",
        "LX20"
      ],
      "Acceptance Criteria (implicit based on R value)": [
        "High correlation (R near 1)"
      ],
      "Reported Device Performance": [
        "R = 0.991",
        "R = 0.984"
      ]
    },
    "Precision Study (Within-Run Imprecision)": {
      "Platform and Sample": [
        "UniCel DxC 800 - SYN 1",
        "UniCel DxC 800 - SYN 2",
        "UniCel DxC 800 - SYN 3",
        "UniCel DxC 800 - Vigil Lipid 1",
        "UniCel DxC 800 - Vigil Lipid 2",
        "UniCel DxC 800 - Vigil Lipid 4",
        "LX20 - SYN 1",
        "LX20 - SYN 2",
        "LX20 - SYN 3",
        "LX20 - Vigil Lipid 1",
        "LX20 - Vigil Lipid 2",
        "LX20 - Vigil Lipid 4"
      ],
      "Acceptance Criteria (implicit based on %C.V.)": [
        "Low imprecision (low %C.V.)"
      ],
      "Reported Device Performance (%C.V.)": [
        "1.66",
        "0.85",
        "0.82",
        "1.83",
        "1.13",
        "0.85",
        "1.05",
        "0.77",
        "0.87",
        "1.64",
        "1.33",
        "1.39"
      ]
    }
  },
  "2_sample_size_and_data_provenance": {
    "Method Comparison Study": {
      "Sample Size (Test Set)": "100 samples for each platform (UniCel DxC 800 and LX20)",
      "Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
    },
    "Precision Study (Within-Run Imprecision)": {
      "Sample Size (Test Set)": "20 replicates for each of 6 samples on each platform (UniCel DxC 800 and LX20), totaling 240 measurements (20 * 6 * 2).",
      "Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
    }
  },
  "3_number_of_experts_and_qualifications_for_ground_truth": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring expert ground truth for classification.",
  "4_adjudication_method": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring adjudication.",
  "5_mrmc_comparative_effectiveness_study": "No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a diagnostic reagent, not an AI-assisted interpretation device for human readers.",
  "6_standalone_performance_done": "Yes, standalone performance was done for both method comparison and precision studies. The studies compare the device's performance against a predicate device and evaluate its consistency.",
  "7_type_of_ground_truth_used": {
    "Method Comparison Study": "The 'ground truth' was established by the predicate method, the Olympus HDLX Assay ([K040692](https://510k.innolitics.com/search/K040692)). The study aims to demonstrate substantial equivalence to this legally marketed device.",
    "Precision Study": "The 'ground truth' is the quantitative measurement itself, assessed for its consistency and reliability (imprecision). There isn't an external 'ground truth' in the same sense as a diagnostic gold standard; rather, it measures the inherent reproducibility of the device."
  },
  "8_sample_size_for_training_set": "Not applicable/Not specified. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense.",
  "9_how_ground_truth_for_training_set_was_established": "Not applicable. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense."
}

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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.

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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For the quantitative determination of low and density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.

Not Found

The provided document is a 510(k) clearance letter for an in vitro diagnostic device, specifically the "HDL/LDL-ADVANCE Calibrator, Cat. No. SE-278". This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance study results that would include detailed acceptance criteria tables, sample sizes for test/training sets, expert consensus details, or MRMC studies.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and comparative effectiveness studies is not available in the provided document.

The document states that the device is a calibrator used to calibrate HDL Cholesterol and LDL Cholesterol assays. Calibrators are reference materials used to establish the relationship between a measurement signal and the concentration of an analyte. The primary evidence for their performance often revolves around their traceability to certified reference materials, their stability, and their ability to produce accurate and precise results when used with their intended assays, rather than diagnostic accuracy metrics like sensitivity or specificity.

To address your specific points based on the limited information available in this type of document:

1. A table of acceptance criteria and the reported device performance: Not available. The document is a clearance letter, not a detailed study report.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a calibrator and not available.
4. Adjudication method for the test set: Not applicable for a calibrator and not available.
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: Not applicable. This device is an in vitro diagnostic calibrator, not an AI-based diagnostic tool for human image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For a calibrator, "ground truth" would typically refer to the assigned values of HDL and LDL in the calibrator material, which are established through a robust metrological process, often traceable to higher-order reference methods or materials, not expert consensus on pathology or outcomes data. This specific information detail is not in the document.
8. The sample size for the training set: Not applicable. This is a calibrator, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. High Density Lipoprotein (HDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Not Found

This document is a 510(k) clearance letter for a medical device called the "HDL-ADVANCE Assay." While it confirms FDA clearance based on substantial equivalence to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data typically found in a full submission.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria from this document alone.

Here's what I can tell you based on the provided text, and where the requested information would typically be found in a full 510(k) submission:

Information NOT available in this document:

1. A table of acceptance criteria and the reported device performance: This letter only states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide the specific performance data (e.g., accuracy, precision, linearity, analytical sensitivity, specificity) or the acceptance criteria used to assess it. This information would be found in the "Performance Characteristics" section of a detailed 510(k) submission.
2. Sample size used for the test set and the data provenance: Not available. This would be part of the study design details in the performance data section.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an in vitro diagnostic (IVD) test for a biomarker. Ground truth for an IVD like an HDL assay is typically established through reference methods or gold standard assays, not expert consensus on images or outcomes.
4. Adjudication method for the test set: Not applicable for an IVD for a biomarker.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are typically used 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 IVD assay. The "device performance" refers to the analytical performance of the assay itself.
7. The type of ground truth used: While not explicitly stated, for an HDL assay, the ground truth would typically be established using a recognized reference method for cholesterol or lipoprotein quantification, or by comparing it to an established, FDA-cleared predicate device.
8. The sample size for the training set: Not available. For an IVD, "training set" might refer to samples used for method development, calibration, or establishing reference ranges, rather than an ML-specific training set.
9. How the ground truth for the training set was established: Not available, but similar to point 7 above, it would involve reference methods or predicate devices.

What this document does tell us:

• Device Name: HDL-ADVANCE Assay, Cat. No. 278-20, 278-50A, 278-50B
• Intended Use/Indications for Use: For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
• Regulatory Class: Class I (general controls)
• Predicate Device: The substantial equivalence determination is made "to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." The specific predicate device(s) are not identified in this letter, but would be in the full submission.

To get the information you are looking for, you would need to access the full 510(k) submission (K041928), which contains the detailed analytical performance data and studies.

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The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.

The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The HDL-EX SEIKEN Assay is a homogeneous method for directly measuring HDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.

The provided text describes a 510(k) summary for the "HDL-EX SEIKEN Assay Kit," a device for quantitatively determining high-density lipoprotein cholesterol (HDL-C). The study presented is a comparative performance study against a predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the comparison to the predicate device, Ultra N-Geneous HDL Cholesterol Reagent. The key metrics evaluated are correlation, slope, and y-intercept for comparative performance, and Coefficient of Variation (CVs) for precision.

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

• Test Set Sample Size: 150 donor samples.
• Data Provenance: Not explicitly stated, but the submission is from a Japanese company (Denka Seiken Co., Ltd.). It is likely these samples were collected in Japan or a similar region, but this is not confirmed. The study appears to be prospective in the sense that the samples were analyzed specifically for this comparison.

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

• This study evaluates an in vitro diagnostic (IVD) assay (a laboratory test), not an imaging device or a clinical outcome-based assessment. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) does not directly apply here.
• The "ground truth" for comparison is the performance of the legally marketed predicate device (Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]) on the same samples. The predicate device itself has established performance characteristics, and its results are used as the reference against which the new device is measured.
• No information is provided about experts interpreting the results beyond the intrinsic performance of the predicate device.

4. Adjudication Method for the Test Set:

• Not applicable in the context of this type of IVD comparative performance study. The comparison is objective, based on quantitative measurements.

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

• No, an MRMC study was not done. This is an IVD device measuring a biomarker, not a device requiring human interpretation of medical images or diagnostic outputs.

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

• Yes, this study represents a standalone performance evaluation of the HDL-EX SEIKEN Assay Kit. As an automated chemistry analyzer test, it operates without human intervention in the interpretive phase. The study directly compares the results of the new assay to the predicate assay.

7. The Type of Ground Truth Used:

• The ground truth (or reference standard) used for the comparative performance study is the results obtained from the legally marketed predicate device, the "Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]." This is a common practice for demonstrating substantial equivalence for IVD devices.

8. The Sample Size for the Training Set:

• The document does not mention a "training set" or any machine learning/AI components. This is a traditional IVD assay, not an AI/ML-based device. Therefore, the concept of a training set is not applicable.

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

• As there is no training set for this traditional IVD device, this question is not applicable.

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HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers.

Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The HDL-Cholesterol plus 2nd Generation test principle uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The cholesterol concentration of HDL-cholesterol is determined enzymatically by cholesterol esterase and cholesterol oxidase coupled with PEG. The color intensity of the blue quinoneimine dye formed is directly proportional to the HDL-cholesterol concentration and is measured photometrically.

This is a 510(k) summary for a medical device, which generally does not include the detailed study design elements you've requested (such as sample size, ground truth establishment methods, or expert qualifications for test/training sets). The primary purpose of a 510(k) summary is to demonstrate "substantial equivalence" to a predicate device, focusing on performance characteristics and how they compare.

However, I can extract the information that is present and provide a table for acceptance criteria and device performance based on the available text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity. Instead, it describes key performance characteristics and compares them to the predicate device, implying that meeting or being comparable to the predicate's performance is the implicit acceptance criterion for substantial equivalence.

Notes on Acceptance Criteria: The primary acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This means the new device must be as safe and effective as the predicate. In this context, "performance" refers to demonstrating that the modified device functions comparably in its intended use, measuring range, method, and sample types, despite minor formulation changes. The NCEP guidelines for expected values are provided as context for interpretation, not as a direct performance metric for the device itself.

2. Sample size used for the test set and the data provenance:

• The 510(k) summary does not provide details on sample sizes for any test sets.
• Data provenance is not explicitly mentioned, but given it's a product from Roche Diagnostics Corporation (Indianapolis, IN, USA), it's highly probable that the studies were conducted in the US. The summary does not specify if data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the 510(k) summary. For an in-vitro diagnostic (IVD) like an HDL-Cholesterol assay, ground truth is typically established by reference methods or validated laboratory measurements, not by expert interpretation in the same way as, for example, a medical imaging device. However, the document does not detail how "ground truth" (i.e., true HDL-C values for comparison) was established for any validation studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not applicable or provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading by multiple experts). For a quantitative IVD, the "adjudication" would be based on the objective comparison of the device's results to a reference method.

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 or provided. MRMC studies are specific to devices that assist human readers (e.g., AI-powered diagnostic software). This device is a direct quantitative assay, not an assistive reading device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This device, an enzymatic in-vitro assay, inherently functions as a "standalone" measurement system. It directly produces a quantitative result (HDL-C concentration) without requiring human interpretation beyond standard laboratory procedures and clinical context. The entire device's performance would be considered standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The 510(k) summary does not explicitly state the type of ground truth used for performance comparison. For quantitative IVDs, ground truth is usually established using:
  • Reference methods: Highly accurate and precise laboratory methods, often more complex or expensive than routine assays.
  • Calibrators and controls: Materials with known and certified concentrations of the analyte.
  • Patient samples compared against the predicate device or a clinical gold standard.

8. The sample size for the training set:

• This information is not provided and is generally not applicable in the context of an enzymatic chemical assay. These assays rely on validated chemical reactions, not machine learning algorithms that require "training sets" in the conventional sense.

9. How the ground truth for the training set was established:

• This information is not provided and not applicable as there is no "training set" in the context of this type of enzymatic assay.

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For the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDL Cholesterol and LDL Cholesterol in serum.

DMA's HDL Cholesterol and LDL Cholesterol calibrator is intended for the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDLC and LDLC in serum.

The provided document is a 510(k) summary for a medical device called "DMA HDL Cholesterol and LDL Cholesterol Calibrator." It describes the device's intended use and technological characteristics in comparison to a predicate device. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes (for training or test sets), expert qualifications, or ground truth establishment relevant to the device's performance.

The document is a regulatory submission summarizing the device's purpose and its substantial equivalence to a predicate device for FDA clearance. It does not include the actual study data or the detailed acceptance criteria and performance results that would be part of a full study report.

Therefore, I cannot provide the requested information from this document.

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This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.

Not Found

This document is a 510(k) clearance letter from the FDA for a device named "HDL-CHOLESTEROL." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested information from this document. The letter focuses on regulatory approval based on substantial equivalence, not on the results of a performance study with detailed acceptance criteria.

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